Many factors contribute to the complexity of women’s healthcare access, including the dynamic nature of health policy and regulations in the United States, insufficient evidence regarding women’s specific health requirements, and ongoing transitions toward patient-centered quality care and outcomes. Avalere’s cross-functional Women’s Health team collated trends, insights, and learnings related to women’s health.

In this eBook, Avalere experts discuss findings on the impact of recommendations for health screening, how technology can aid in delivering care, and the disparities that exist in women’s healthcare services.

The eBook includes chapters on:

• Factors impacting women’s health across the lifespan
• Technology-driven innovations in women’s health
• The impact of breast cancer screening recommendations on inequities
• Efforts to address sex and gender disparities in cognitive health
• Cervical cancer screening and diagnosis patterns
• Impact of caregiving on mental health
• Innovations in fertility and family-forming care
• The evolution of lactation care

Download the free women’s health eBook here.

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The American Cancer Society (ACS) and the US Preventive Services Task Force (USPSTF) have both issued recommendations for cervical cancer screening frequency across age groups. Typical screenings for cervical cancer include a Papanicolaou (Pap) test and/or Human Papillomavirus (HPV) test. Recommendations from both organizations are similar, although USPSTF recommends screenings to begin at age 21 and the ACS at 25.

Figure 1. ACS and USPSTF Screening Recommendations Across Age Groups

Source: National Cancer Institute. ACS’s Updated Cervical Cancer Screening Guidelines Explained. 2020.

Despite the Affordable Care Act (ACA) requirement that most commercial health insurers provide coverage of women’s preventive healthcare (including cervical cancer screenings) with no cost sharing, most women are not receiving cervical cancer screenings in compliance with recommendations. There are notable disparities by insurance type (e.g., commercial vs. Medicaid) and age.

Cervical cancer is the fourth most common cancer in U.S. women aged 15-44. The mortality rate for Black and Native American women is approximately 65% higher than for White women. Disparities in survival rates also exist. Surveillance, Epidemiology, and End Results (SEER) data from 2014 to 2020 shows that Non-Hispanic Black women had the lowest five-year survival rate (58.1%). Additionally, younger women (15-39) have the highest survival rates, while women 75+ have the lowest.

Avalere’s Analysis

Methodology

Avalere researched the utilization of recommended cervical cancer screening in women, prior to a cervical cancer diagnosis. Avalere performed a retrospective analysis of women 26+ years of age who were newly diagnosed with cervical cancer in 2021-2022, and whether they were screened for cervical cancer in the five years prior to their diagnosis (age 21+ years), to capture the age range for screening in guideline recommendations. Avalere conducted this analysis using a convenience sample of Managed Medicaid, commercial insurance, and Medicare Advantage adjudicated claims. The analysis also looked specifically at women continuously enrolled in the insurance type for the analysis timeframe to ensure capture of all testing. Since the screening recommendations do not recommend regular screening past 65, the Medicare FFS population was not included.

Findings

The analysis revealed that around 29% of the approximately 1,500 women aged 21+ years in the sample received at least one screening Pap test in the five years preceding their diagnosis. In this group, 82% (N=1,202) of women were in the age group 21-65 years recommended for screening. The remaining women 18% (N=262) were older than age (aged 65+) for general population recommendations for screening, but did receive screening. Despite current recommendations for Pap tests every three years, the majority of the women (approximately 70%) in this sample did not undergo any screening Pap test within the five-year period preceding diagnosis.

This analysis further showed that those receiving regular Pap tests were diagnosed at younger ages, with the highest number of diagnoses occurring in the 26–40 age range. Conversely, in the group that did not receive a screening Pap test in the five years prior to diagnosis, the number with a diagnosis increased with age, peaking in the 56-60 age group. The analysis also found 23% of women aged 71+ that were diagnosed with cervical cancer also underwent screening, which may have been indicated based on meeting personal criteria. Since age and severity at the time of diagnosis are directly correlated with survival in cervical cancer, diagnoses at older ages may be concerning with regards to outcomes. Additionally, as the likelihood of comorbidities increases with age, overall treatment costs may rise for women diagnosed in older age cohorts.

Figure 1. Number of Women Diagnosed with Cervical Cancer in 2021–2022 That Received Screening Within the Five-Year Period Prior to Diagnosis, Continuously Enrolled, Across Age Groups (N=1,464)

The analysis did not find any meaningful difference in the presence of metastatic cancer (early vs. advanced). However, metastatic cancer may not be captured consistently in adjudicated claims for cervical cancer.

Conclusion

Further research is needed to analyze the breakdown of cervical cancer cases by race and ethnicity to understand any disparities in screening and outcomes. Additionally, researching healthcare resource utilization (HCRU) costs post-diagnosis will help stakeholders understand the cost of not screening per recommendations and how HCRU varies based on the age at which cervical cancer is diagnosed. The 71+ population can also be further studied in Medicare FFS data to understand the impact of limited screening criteria, on the early diagnosis of women in this age group.

Current and additional findings can help inform stakeholders in the primary care, gynecologic, and cervical cancer space. Healthcare providers play an important role in communicating the importance of screening. For payers, the costs associated with treating cervical cancer patients may drive a focus on early screening and access to screening. Manufacturers of cervical cancer diagnosis tests and therapies can identify barriers within the patient journey and partner with providers to ensure early and timely screening and diagnosis. Additional research into demographic factors, age at diagnosis, and long-term costs could further inform screening guidelines, resource allocation, and targeted interventions to address cervical cancer disparities.

How Can Avalere Help?

Stakeholders across the care continuum including providers, payers, patients stand to benefit significantly from a proactive approach to preventive care and early detection. Avalere supports these stakeholder address key questions and initiatives like those identified in this study through:

• Stakeholder primary research can provide insights into stakeholder decision-making motivations and gaps in the care continuum;
• Patient support services guidance can support education and access solutions to overcome barriers to care.

To learn more, connect with us.

Data Source

For this analysis, Avalere used commercial and Managed Medicaid claims data from Inovalon’s proprietary “Medical Outcomes Research for Effectiveness and Economics” (MORE2) Registry®, accessed by Avalere via an Agreement with Inovalon, Inc.

The post Most Women with Cervical Cancer Were Not Screened Before Diagnosis appeared first on Avalere Health Advisory.

Cognitive health is defined as the ability to clearly think, learn, and remember, and is distinct from mental health, which focuses on psychological and emotional functions associated with the brain.

Aging causes cognitive decline, but some adults experience a more pronounced decline in executive functions and memory than expected for their age. This decline, influenced by hereditary and lifestyle factors, can lead to conditions like Alzheimer’s disease and related dementias (ADRD), which progressively impair daily activities. While age is the primary risk factor, sex- and gender-specific factors also contribute to cognitive health decline.

Sex Differences in Cognitive Decline

Research shows that women decline faster in global cognition and executive function than men. During perimenopause and menopause, women often experience “brain fog” due to a sharp decline in estrogen, which has a neuroprotective role. Post-menopause, lower estrogen levels are linked to higher cardiovascular disease risk, making women more susceptible to vascular dementias than men of the same age.

Women experiencing cognitive decline tend to outperform men on verbal memory examinations testing cognitive decline, indicating additional cognitive reserve in women over men. This can delay clinical intervention in women, leading to more advanced disease at diagnosis and affecting outcomes.

Women comprise two-thirds of Alzheimer’s disease (AD) cases and have twice the risk of developing it compared to men. This disparity is partly due to genetic and biological factors, such as a higher likelihood of carrying the APOE4 mutation, a major genetic risk factor for early-onset AD. Additional studies are needed to understand why we see sex and gender differences in AD risk, burden, and progression, and to advance women-focused care and treatment.

Economic Impact of Women-Focused ADRD Research

Women have long been understudied and underrepresented in research and clinical trials, with the lack of funding even more pronounced in conditions that affect women exclusively (e.g., menopause) or disproportionately (e.g., ADRD). Despite the high burden of ADRD on women, 12% ($287.8 million) of the National Institutes of Health’s (NIH) 2019 budget for AD went to women-focused research.

The total cost of AD to families, businesses, and the government is estimated to exceed $300 billion per year. Part of this cost comes from the overwhelming and often unpaid caregiver burden for ADRD. Moreover, women make up 60% of caregivers for people with AD.

A 2021 report found that doubling NIH funding for women-focused ADRD research would yield $930 million in economic returns through reduced nursing home care and fewer years lived with ADRD, highlighting the benefits of investing in women’s ADRD research.

Recent Initiatives and Ongoing Research

There are several ongoing initiatives designed to address gaps in women’s health over the next several years, with ADRD as an area of interest.

Federal Women’s Health Initiatives

The executive order allocates $200 million to the NIH for women’s health research and $100 million to the Advanced Research Projects Agency for Health (ARPA-H) for innovative research projects that may otherwise not be granted due to their high-risk nature. One topic of interest for ARPA-H is “Advancing Women’s Brain Health Via Lymphatic Targeting,” which prioritizes research on the influence of sex differences in the lymphatic system on brain health in women to inform the prevention, early diagnosis, and treatment of neurodegenerative diseases.

In addition to enacting the executive order, the Biden administration has urged federal legislators to create and invest $12 billion in a central fund for women’s health to galvanize research. The national focus on women’s health and increased research is important for stakeholders to consider in developing their own priorities and research direction.

Work With Us

Avalere is uniquely positioned to assist stakeholders in understanding the patient journey of women facing cognitive health issues and can leverage a bench of experts in regulatory strategy, evidence strategy, and patient access to focus on clinical trial design, new innovations, and access considerations in this space. Avalere can assist clients with primary research to better understand the gaps and barriers women face in diagnosing and treating conditions related to cognitive decline. To learn more about how Avalere can assist you, connect with us.

The post Addressing Sex and Gender Disparities in Cognitive Health appeared first on Avalere Health Advisory.

Increased cultural focus on women’s health is driving a paradigm shift towards improved innovation and investment in products and services. At the same time, longstanding disparities in access to care have persisted, garnering increased attention within health equity discussions.  

For example, in 2023 the Biden administration launched an initiative to accelerate and increase research in women’s health to address these disparities. Women face many barriers within the current healthcare system, including the underdiagnosis of medical conditions, fragmentation of the care continuum, inadequate representation in clinical trials, and ambiguities surrounding insurance coverage for necessary care. These obstacles have contributed to the United States displaying less favorable metrics and worse outcomes than other developed countries despite spending the most on healthcare.  

One notable example of this is maternal health outcomes. A Commonwealth Fund analysis found that the United States has the highest maternal mortality rates when compared to other high-income nations, with about 24 maternal deaths per 100,000 live births; this is substantially higher than the next highest country (New Zealand) at 13.6 maternal deaths. Data from the Centers for Disease Control and Prevention has identified racial disparities in US maternal health outcomes: women of color are three times more likely to die from pregnancy-related causes than White women.  

Further, women have historically been underrepresented in medical research, employed women’s out-of-pocket costs are an estimated to be $15.4 billion higher than those of men, and social and political stigma are widespread within women’s health. Health disparities are further compounded by provider bias, structural racism, lack of access or affordability, and systemic challenges. 

Current structural challenges in coverage, coding, and reimbursement have triggered the need for innovative paths to bring necessary services to market, such as self-pay or employer-covered benefits. In women’s health, digital health companies are working to close gaps within fundamental access challenges, with a market potential of around $50 billion in 2025. Stakeholders have focused on improving access to and awareness of care for more innovative solutions in fertility services, menopause care, and chronic disease management. As these stakeholders push to unlock expanded coverage, coding, and payment options for women’s health, the FemTech space can assist in providing broadened and equitable care.    

What is FemTech?

The term “FemTech”, coined by Ida Tin, encompasses technology-based innovation in the women’s health space, including products, diagnostics, medical devices, digital therapeutics, consumer applications, and services. FemTech intends to address female health issues by developing evidence, improving consumer experience, improving diagnoses, and ultimately improving overall health and wellness. While the term is just that—a term—it describes a new wave of inclusive innovations to support women and their families. 

Innovations in women’s health have often centered around the following subsectors, likely addressing issues in more than one sector at a time. 

Figure 1: Interrelated Women’s Health Technology Sectors

Clearly, women’s health extends beyond maternal health.  As of 2021, companies that provided pregnancy services comprised about 21% of the FemTech market, followed closely by those offering reproductive health and menstrual health services. The industry strives to destigmatize discussions and treatment related to women’s health, addressing areas such as sexual wellness and education, menopause, pelvic healthcare, and chronic disease management. 

Women’s health technology encompasses various product types and conduits for service, including consumer products, devices (e.g., wearables and hardware), apps, digital platforms, healthcare software, and diagnostics. The top three product types collectively account for over 50% of the product share within women’s health technology. 

Figure 2: Proportion of Product Types in FemTech

As of 2024 estimates, the FemTech market has an estimated value of $50 to $60 billion, marking a substantial increase from its $130 million value in 2013.  Projections indicate that the market is expected to sustain its growth, with an anticipated compound annual growth rate (CAGR) of 16% from 2023 to 2032.  

Figure 3: Projected FemTech Market Size, 2020–2025

Source: Ariston Advisory & Intelligence, FemTech Market Size 

Reimbursement for FemTech Products and Services

Payment within the FemTech space has deviated from traditional methodologies, as many of the products and services offered may not be covered by typical health plans through medical or pharmacy benefits. Payment is often routed through one of three end-markets: traditional health plan coverage, employer-sponsored coverage, and direct-to-consumer models. The latter two markets are currently the more common, although all three face unique challenges. Coverage, coding, and payment structures—which are critical to defining reimbursement—are often unclear. In addition, the perceived value of products and services may be variable, and the awareness of need, demand, and service options is limited.  

Until recently, traditional insurers often did not realize the value of many women’s health services for which FemTech is garnered. While traditional coverage is expanding, the market has also employed alternative pathways such as direct-to-consumer models, employer carve-outs, and outsourced care management models. For example, Maven Clinic, Ovia, or Wildflower offer digital solutions for Medicaid beneficiaries by partnering with managed care organizations to enhance maternity services. Health plans have sought to support employers in this arena as well. For example, UnitedHealthcare (UHC) launched its UHC Hub (a digital health contracting platform) with partners Maven Clinic, Cleo, and Wellthy in January 2024. In the menopause space, groups like Midi Health, Elektra Health, and others are finding traction with employers and health plans by billing for services as an in-network provider. While these payment methodologies and avenues are useful, they are not sustainable or equitably distributed within the women’s health technology space, as they are dependent upon patients’ disposable income, employers’ offerings, and reactive coverage options.  

Learn More about the Potential of FemTech

Little research has been done to assess traditional payer perspectives of women’s health technology, including coverage of, payment for, and value of products and services. While subsectors such as fertility services and menopause have slowly gained traction among employer benefits, Avalere is primed to research additional subsectors within women’s health that may see increased volume through technology.  

Advancing the sector will require multi-stakeholder partnerships, including provider engagement to understand how to incorporate FemTech solutions into the treatment journey and improve care delivery, as well as leveraged payer and employer perspectives on evidence needed to drive broader coverage of these solutions. It will also require increased access to patients to drive improvements in health equity, and improved understanding of potential payment and care delivery models.  

Avalere is uniquely positioned to support innovators in navigating these policy, access, and evidentiary questions. To speak with an Avalere subject matter expert on any of these issues and what they mean for your organization, connect with us. 

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Table 1: Summary of USPSTF Recommendations for Breast Cancer Screening

While the updated recommendation is more closely aligned with other guidelines in terms of age of screening initiation and individual risk, the USPSTF recommendation continues to differ from other recommendations regarding the recommended screening interval (see Table 2).

Table 2: Overview of Recommendations Guideline Developers

Notably, several guideline developers recommend annual mammograms in recognition of evidence that regular mammograms can identify breast cancer at an earlier stage, when interventions are more likely to be successful. The biennial screening interval that the USPSTF currently recommends may delay the initial breast cancer diagnosis, leading to later-stage diagnoses with detrimental consequences for treatment outcomes. This is particularly true for women of color, especially Black women, who, despite having a 4% lower overall risk of developing breast cancer when compared to White women, are more prone to developing aggressive, advanced-stage breast cancer at a younger age.

Breast Cancer Disparities

While Black women have similar or higher rates of mammography screening, they are disproportionately diagnosed with breast cancer beyond stage 1 (when intervention may be more complex) as compared to other racial and ethnic groups. Additionally, the breast cancer mortality rate for Black women is 40% higher than that of White women. Rates of one aggressive form of breast cancer, triple-negative breast cancer (TNBC), which accounts for 15–20% of all cases of breast cancer, are higher in Black women (33.8 cases per 100,000) women compared to White (17.5) and Hispanic (14.7) women. The significantly higher age-adjusted incidence of TNBC in Black women as compared to White women was limited to younger women aged 20–44.

Racial disparities in breast cancer outcomes stem from a complex interplay of social and non-biological factors. While the current screening recommendations are informed by existing evidence, there is a concern that they may exacerbate these health disparities among Black women who are at a heightened risk of developing aggressive forms of breast cancer, including more aggressive cancers like TNBC.

Application of the Health Equity Framework

In acknowledgement of racial disparities in breast cancer, the USPSTF applied its health equity framework to formulate the recent breast cancer recommendation. Published in 2023, the framework and its accompanying checklist were designed to ensure that the Task Force incorporates the health equity perspective throughout the recommendation process—from topic nomination to dissemination—through equity-focused prioritization criteria, engagement with diverse stakeholders, and incorporation of equity-relevant research questions (i.e., looking beyond effectiveness and harms), among other factors.

To that end, the Task Force incorporated several key and contextual questions focused on disparities in breast cancer incidence, outcomes, and access when developing the breast cancer recommendation. Specifically, the Task Force commissioned modeling studies specific to Black women and featured contextual questions aimed at understanding the drivers of and methods to address disparate health outcomes. Additionally, the USPSTF considered the importance of equitable access to appropriate follow-up care and testing, including biopsies.

Despite using the framework, the published recommendations may not adequately address health disparities, suggesting that further research is needed to ensure future recommendations are appropriate for all women. In fact, the Task Force highlighted the need for additional research to better understand and address high breast cancer mortality in Black women, including how variations in care may lead to increased risk of breast cancer morbidity and mortality, as well as strategies for addressing this disparity.

Furthermore, the Task Force called for research to examine whether the balance of benefits and harms related to annual breast cancer screening is different for Black women than it is for all women. Though the Task Force largely focused on Black women because it is the group that experiences the poorest health outcomes from breast cancer, it also emphasized that all studies should prioritize inclusion of all racial and ethnic groups so we can understand whether the effectiveness of screening, diagnosis, and treatment varies by population.

Areas for Additional Research

USPSTF prioritizes “high quality” evidence, such as that from randomized controlled trials, when making or changing its recommendations. However, historically, Black women have been underrepresented in these studies, which may lead to standards of care that do not adequately address the specific needs of Black women and potentially overlook differences that could impact screening effectiveness and subsequent outcomes. For instance, more than 10% of Black women with breast cancer are diagnosed before age 40, which suggests the recent shift in USPSTF recommendations may still miss many Black women, despite reflecting progress.

Although USPSTF acknowledges that reducing the age of screening is not going to improve inequities in Black women they are urgently calling for more evidence to understand specific risks in Black women, until then USPSTF has acknowledge that inequities in breast cancer outcomes will continue. To address these disparities and improve the effectiveness of breast cancer screening, researchers should consider opportunities to include a diverse range of participants, including Black women under 40, in research studies and randomized control trials to inform screening guidelines to advance understanding and improve outcomes in breast cancer treatment and prevention.

Dive Deeper

Avalere is uniquely positioned to assist stakeholders in understanding USPSTF’s recommendations and can leverage a bench of experts in regulatory strategy, evidence strategy, and patient access to focus on clinical trial design, new innovations, and access considerations in this space. To learn more about how Avalere can assist you, connect with us.

The post Breast Cancer Screening Recommendations May Drive Inequities appeared first on Avalere Health Advisory.

The American Cancer Society (ACS) and the US Preventive Services Task Force (USPSTF) both have issued recommendations for cervical cancer screening frequency across age groups. As of 2020, the ACS recommends that women begin screening at age 25 (up from 21 in previous recommendations) and that those ages 25–30 be screened every three years. This differs from USPSTF’s 2018 recommendation that screenings start at age 21 and occur every three years until age 30. Both organizations recommend only Papanicolaou (Pap) tests for women ages 21–30. For women ages 31–65, both organizations recommend a Pap test every three years, a human papillomavirus (HPV) test every five years, or HPV/Pap co-testing every five years. In 2021, the American College of Obstetricians and Gynecologists, American Society for Colposcopy and Cervical Pathology, and Society of Gynecologic Oncology endorsed USPSTF’s cervical cancer screening recommendations.  

The Affordable Care Act (ACA) mandates that most commercial health insurers provide coverage of women’s preventive healthcare—such as mammograms and screenings for cervical cancer—with no cost sharing. Screening can detect precancerous changes and cervical cancer before symptoms are present. Early detection of cervical cancer may facilitate earlier interventions to reduce risk of the advancement to more difficult-to-treat stages of cervical cancer, potentially saving lives through effective treatment strategies. HPV infection is associated with nine in ten cervical cancers; therefore, screenings inform the risk of developing cervical cancer in the future.  

The incidence and mortality rate of cervical cancer remains relatively higher among certain populations. According to the Centers for Disease Control and Prevention, every year in the United States, about 11,500 new cases of cervical cancer are diagnosed and approximately 4,000 women die of this cancer. Rates in African American, American Indian/Alaska Native, and Hispanic women are disproportionately higher than those of White women.  

Claims Analysis

Methodology 

Avalere performed a retrospective analysis of women of screening age in a convenience sample of Managed Medicaid and commercial insurance claims to identify the utilization of cervical cytology Pap smears in order to determine how many women received screenings consistent with USPSTF and ACS recommendations.  

We analyzed 2018–2022 claims data to determine the proportion of women between the ages of 21 and 65 who received at least one Pap smear during that time. We used a five-year range for the claims data to account for any care delays or barriers due to the COVID-19 pandemic. To capture women eligible for screening in the five-year timeframe, we capped the upper age to enter the analysis at 61, since women who are older in 2018 would not be eligible for screening  for the full five-year period. The analysis also looked specifically at women continuously enrolled in the insurance type for the entire timeframe. 

Findings 

The analysis showed that about 38% of the approximately 12 million women in this sample received at least one cervical cancer screening. Less than half of women with commercial insurance (41%) and even fewer with Managed Medicaid (33%) insurance received at least one cervical cancer screening during the five-year period (see Figure 1).  

Figure 1. Rates of Cervical Cancer Screening in Women 21–65 Years of Age, by Insurance Type (2018–2022) 

Avalere also analyzed cervical cancer screening rates by age group, since USPSTF and ACS recommendations differ for women less than 30 years of age.   

In the commercial payer population (N= 7,604,391), women in the 26–40 age group had marginally higher screening rates (45%) when compared to the 21–25 age group (39%). We observed a steady decline in percent of women who received at least one cervical cancer screening from ages 41–61 (see Figure 2).  

Figure 2. Rates of Cervical Cancer Screening for Commercially Insured Women 21–65 Years of Age, by Age Group (2018–2022)

In the Managed Medicaid population (N= 4,482,500), women between the ages of 21 and 30 had marginally higher screening rates (38%) than women between the ages of 31 and 65 (30%). We observed a steady decline in screening rates across age groups, from 38% for women aged 21–25 to 22% for women aged 56–61 (see Figure 3). 

Figure 3. Rates of Cervical Cancer Screening for Women Covered by Managed Medicaid, 21–65 Years of Age, by Age Group (2018–2022)

Barriers to Access

In navigating the landscape of cervical cancer screenings, an array of challenges emerges. 

• Locality Differences: Published studies has shown that women living in rural areas have worse cancer survival outcomes due to lack of screening services and long distances to access care.  
• Increased Risk Due to HIV: According to the World Health Organization, approximately 5% of cervical cancer diagnoses are traceable to HIV. The immunosuppressive nature of HIV makes women with HIV more susceptible to high-risk HPV, which is the underlying cause of almost all cervical cancer cases.  
• Increased Risk Due to HPV: Nearly all (99.7%) of cervical cancer cases are caused by persistent HPV infection. Published cohort and case-controlled studies have shown that sexual activity at a younger age and with a greater number of partners increases the risk of obtaining HPV. 
• Costs of Follow-on Testing: Although the ACA may enable cervical cancer screening with no cost sharing, follow-on tests may not be covered by every insurer, leading to further affordability challenges and impeding early detection. Published studies have shown that women were paying anywhere from $100 to $1,000 out-of-pocket for additional tests after initial screening. 
• Confusion on Screening Recommendations: Inconsistency around screening recommendations and poor provider and patient education around cervical cancer can exacerbate the problem.  
• Cultural and Religious Factors: Some women may face barriers to gynecological care due to cultural practices and belief systems, impacting individuals’ ability or willingness to undergo screenings.  
• Emotional and Mental Factors: Emotional barriers, such as embarrassment or fear of results, may impede screening. 
• Mistrust in the Healthcare System: Due to historic and ongoing medical mistreatment of minorities, individuals may be deterred from seeking timely screenings.  

Addressing these diverse obstacles is essential for promoting equitable healthcare and fostering proactive preventative measures. 

Conclusion

The data shows that compounding factors of women’s identities impede access to cervical cancer screenings. Women covered by Medicaid and private insurance showed were less likely to be screened for cervical cancer as they got older, with women aged 56–61 having the lowest screening rates. Women covered by Managed Medicaid had lower screening rates than women covered by commercial insurance. Although the ACA mandates coverage of women’s preventive health care with no cost sharing, we are still observing more than 50% of women in the commercial space not receiving any cervical cancer screening in a five-year study period. 

Stakeholder Call to Action

Stakeholders should monitor any legislative or regulatory changes aimed at improving cancer screening rates in the United States to improve patient outcomes. As the claims analysis shows, removing cost sharing for preventative services does not guarantee that women will receive cervical cancer screenings. Manufacturers with pipeline products in cervical cancer detection and/or treatment should consider the various types of barriers (e.g., educational, financial, cultural, and emotional) and seek patient support solutions to increase screening rates and subsequently, diagnoses and treatment. Providers can work with other interested stakeholders to better educate patients on the importance of screening for cervical cancer at an early age. Payers can explore improving screening rates through coverage of follow-on testing and through any value-based incentives to providers for properly counseling patients. 

How Avalere Can Help

Avalere is committed to addressing barriers that patients face when accessing cervical cancer screenings. Avalere can support clients evaluate the current landscape for diverse groups of women, analyze the potential pathways for patient access and provide strategic insights informed by patient perspectives. Specifically, Avalere can assist stakeholders to evaluate the state and federal legislative developments to observe cervical cancer diagnosis screening and disparities to inform implications to access and inform portfolio decisions. 

Avalere is also able to conduct qualitative and quantitative analyses. Avalere can analyze coverage, coding and reimbursement of women’s preventive health services to provide perspectives on coverage, healthcare utilization and financial barriers to women for screenings. Avalere can also parlay those findings with primary research from patients, payers and/or providers of access barriers and challenges.  

To speak with a women’s health subject matter experts, connect with us. 

Data Source

For this analysis, Avalere used commercial and Managed Medicaid claims data from Inovalon’s proprietary “Medical Outcomes Research for Effectiveness and Economics” (MORE2) Registry®, accessed by Avalere via an Agreement with Inovalon, Inc. 

The post Cervical Cancer Screening Rates Differ Across Demographics appeared first on Avalere Health Advisory.

Figure 1: Rates of Biennial Breast Cancer Screening in Women 50-74 Years of Age, by Payer Type

Figure 2: Rates of Biennial Breast Cancer Screening in Medicare FFS, for Women 50-74 Year of Age, by Race/Ethnicity (2018-2019)

 

Figure 3: Rates of Biennial Breast Cancer Screening in Other Payer Types, for Women 50-74 Year of Age, by Race/Ethnicity

The post Stakeholders Address Disparities in Breast Cancer Screening appeared first on Avalere Health Advisory.

On April 7, a US District court ruling in Texas in The Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (FDA), issued a preliminary injunction, partially in favor of the plaintiffs, citing the public’s interest and resulting in a less restrictive ruling. The court issued a Section 705 stay “temporarily suspending” the FDA’s authority and the effective date of the FDA’s initial approval of mifepristone. The drug, commonly used in combination with misoprostol for medication abortions, received FDA approval in 2000. The Department of Justice has appealed the Texas decision and filed an emergency motion to block the decision from going into effect until after the appeal has been heard. On April 12, plaintiffs sought a nationwide injunction, but the federal appeals court issued a preliminary injunction, ruling partially in favor of the plaintiffs. The Justice Department has expressed intent to seek “emergency relief from the Supreme Court to defend the FDA’s scientific judgment.” In a separate case, Washington State et al. v. FDA, 12 Democratic states challenged the FDA’s restrictions on mifepristone’s distribution. The presiding judge issued an injunction preventing any changes to the drug’s current availability under its January 2023 Risk Evaluation and Mitigation Strategy (REMS).

Implications of Case Rulings

Stakeholders and the media have engaged in a robust conversation about the rulings’ effects on access to medication abortion and existing disparities based on factors such as geography. However, these decisions also raise broader questions about the implications to the regulatory process and access to similar products that may face political opposition. The questions below begin to explore these impacts that extend beyond abortion to other FDA decisions regarding historical court deference to agency interpretation of statutes and regulations, approvals of products that may face political opposition, and access and coverage variations across states.

1. How will the Texas and Washington decisions impact future access to additional products under public scrutiny?

As with abortion medications, vaccines and other products have been subject to public scrutiny. If the Texas court decision suspending agency approval is upheld, it may increase uncertainty around access to existing and pipeline products that could be controversial.

2. How will courts approach deference to federal agencies in subsequent cases?

The mifepristone rulings call into question the FDA’s consideration of safety and efficacy and interpretation of the statutory term “illness.” Historically, judicial deference is given to federal agencies to interpret statutory language and regulations following the 1984 landmark Supreme Court case, Chevron USA, Inc. v. Natural Resources Defense Council, Inc., and the 1997 case, Auer v. Robbins. However, deference to agency interpretation of statute and regulation has been increasingly challenged in court. In the Texas case, plaintiffs argued that Auer deference is inappropriate because Auer “requires courts to yield to an agency’s interpretation of an ambiguous regulation,” but in this case the regulation at hand is “plain and not ambiguous.” If the mifepristone decisions overturning or suspending FDA’s approvals are upheld, the rulings will add to recent Administrative Procedure Act cases challenging deference to FDA agency interpretation for subsequent court cases, thereby potentially increasing the risk of additional scrutiny of future FDA interpretations of statute or regulations.

3. What will manufacturers need to consider when pursuing new indications to limit uncertainty in access?

Manufacturers analyzing current or planned label language and clinical trial design have other issues to consider as well, because the Texas decision also weighed in on minor deviations between conditions of use and clinical trial protocols for mifepristone. This may result in uncertainty around future use of clinical trial criteria in label language, approval of indications to label, or appropriateness of current label language. Questions also remain about whether off-label use for similar drugs may be subject to a similarly high degree of scrutiny.

The plaintiff in The Alliance for Hippocratic Medicine v. FDA argued that the agency was “arbitrary and capricious” in the label requirements for mifepristone, saying that the label omits protocols originally used in US clinical trials submitted as evidence for approval. The FDA reviewed the label and the REMS in 2016 following an evidence-based request from the manufacturer. The review concluded that there was sufficient evidence to omit certain original protocols due to “no new safety concerns” and “the number of adverse events appear[ing] to be stable or decreasing.”

4. What will manufacturers need to consider when seeking product approvals through the accelerated approval pathway?

The Texas case scrutinizes Subpart H and the FDA’s accelerated approval pathway (AAP), creating another consideration for stakeholders planning to use or currently utilizing the AAP to develop a product. The accelerated approval pathway  has also been in the spotlight recently due to legislative and regulatory reforms. For example, legislation has been proposed in Congress to increase funding for oversight of the accelerated approval process and the creation of a cross-disciplinary oversight council. These cases are likely to further increase scrutiny of the pathway, adding to the factors manufacturers must take into account if they are considering utilizing the pathway or already proceeding in developing a product via the AAP.

5. How will REMS be operationalized under varying guidance from courts, agency, and states?

With conflicting opinions on the mifepristone REMS, the rulings also raise questions about the implementation of REMS requirements across varying guidance.  The Washington plaintiffs contend they “seek to enjoin the application of any REMS, such that mifepristone can be prescribed just like the 20,000+ other drugs that don’t have one”. Although the FDA’s decisions around the REMS is federal, states may impose additional restrictions outside of the REMS that restrict access to FDA-approved products, such as Mississippi’s requirements of a 24-hour waiting period for dispensing mifepristone following initial examination and ingestion of the drug in the presence of the prescriber. Conflicting guidance on restrictions of use can lead to variation in access and potentially worsened disparities in medical care.

6. How will the conflicting interpretations of statute for the term “illness” between courts and agency impact coverage of pipeline and on-market products?

Plaintiffs in the Texas case contend that pregnancy is not an illness and therefore the FDA was “exceeding its authority” by approving mifepristone under Subpart H. Plaintiffs define “illness” as “an unhealthy condition of body or mind” or “a particular abnormal condition that negatively affects the structure or function of all or part of an organism, and that is not immediately due to any external injury.” A  2008 review conducted by the Government Accountability Office on the FDA’s approval and oversight of mifepristone found that the FDA concluded in its third and final review of the drug application that “termination of unwanted pregnancy is a serious condition and imposing restrictions under Subpart H was necessary.” If ultimately upheld, the Texas decision could increase risks associated with the durability of coverage and approval of prophylactics and other existing and pipeline products targeting conditions that do not meet the definition of “illness” as defined by the case.

Future Outlook

Amid all this uncertainty, stakeholders should monitor future court decisions and stakeholder actions to understand potential impacts on access to other FDA-approved products. To learn how Avalere’s regulatory experts can help provide a 360° perspective on potential risks and implications for product success, connect with us.

The post 6 Ways the Mifepristone Rulings May Impact Future FDA Approvals appeared first on Avalere Health Advisory.

Figure 1. National Utilization of Select IVF and Storage Services per 1,000 Women Aged 18–45

Figure 2. National Prevalence of Fertility-Related Diagnoses per 1,000 Women Aged 18–45

The post After Roe, Growing Fertility Industry Faces Risks at State Level appeared first on Avalere Health Advisory.

Read Avalere’s analysis of these 10 questions on the impact of Dobbs:

• Will patients be able to access abortion services out of state?
• Will states scale back flexible telehealth policies, especially those allowing providers to practice across state lines?
• Who decides whether abortion is necessary to preserve a pregnant person’s life or health?
• What effect might declining abortion rates have on the disparities in maternal mortality rates?
• Has the outlook for November’s state and federal elections changed following the Dobbs ruling, and what will that mean for abortion policy in the future?
• How might Dobbs affect patient access to contraception?
• What effects might this ruling have on care following pregnancy losses such as miscarriages?
• How will the definition of personhood impact the assisted reproductive technology industry?
• Could this ruling impact patients’ relationships with providers and pharmacists?
• How might Dobbs influence the popularity of or investment in digital reproductive health solutions?

Future Outlook

Stakeholders are just beginning to identify, understand, and experience Dobbs’s impacts, and federal policymakers are grappling with its implications. Over time, the ruling’s direct and indirect effects are likely to have widespread implications across the healthcare system. As the Dobbs ruling and other health policy developments change the healthcare landscape, Avalere’s 360-degree perspective on healthcare can help your organization to prepare for success in the new environment.

To stay up to date on changes in healthcare policy, connect with us.

The post 10 Questions on Dobbs v. Jackson’s Reproductive Health Impact and More appeared first on Avalere Health Advisory.

The study utilized Inovalon’s MORE² Registry®, a multi-payer database that captures the enrollment and claims data of more than 338 million commercial, Medicare FFS, Medicare Advantage, and Managed Medicaid beneficiaries, as well as Acxiom’s InfoBase® Geo database, to integrate patient-specific social determinants of health information at the 5-digit ZIP code level. The goals of the analysis were to measure adherence to United State Preventive Services Task Force (USPSTF) breast cancer screening guidelines before and during the emergence of COVID-19 and to evaluate whether the PHE differentially impacted screening utilization among certain high-risk sub-populations.

The results can be used to inform revisions to the USPSTF breast cancer recommendation and will support better understanding of how and to what extent the pandemic has the exacerbated health disparities in patient care, as outlined in President Biden’s revitalized Cancer Moonshot Initiative.

To stay up to date with Avalere research, connect with us.

Avalere Health is an Inovalon company, a leading provider of cloud-based platforms empowering data-driven healthcare. We believe in the power of data, informing actionable insights, delivering meaningful impact, and driving stronger patient outcomes and business economics.

The post Avalere Data on Breast Cancer Screening Disparities Published in AJMC appeared first on Avalere Health Advisory.

Figure 1. Proportion of Focus Group Participants Mentioning Key Treatment-Related Decision-Making Factors

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Because 60% of the deaths linked to pregnancy are preventable, it is important to understand why women of color face greater risks, what care gaps exist along the maternity care continuum, and how specific health interventions can reduce the loss of life.  The maternal mortality disparity is partly due to social determinants of health, such as poverty and lack of access to care, which impact communities of color more substantially than White communities. Moreover, various clinical risk factors across the stages of pregnancy and birth are more prevalent among women of color and are further exacerbated by those social determinant of health factors. To reduce pregnancy-related deaths, shared decision-making (SDM), standardized protocols, and other strategies must be used as tools to create a comprehensive approach to providing equitable maternity care to women of color.

Background

Maternal mortality is a high-profile global health indicator defined as death occurring during pregnancy, childbirth, or up to 42 days after birth due to pregnancy-related health problems. A recent Commonwealth Fund study found American women aged 15–39 experienced 14 deaths per 100,000 live births, a rate higher than Canada, Australia, New Zealand, and 7 Western European nations. Sweden reported the lowest rate in the group, with 4 maternal deaths per 100,000 births; Norway and Switzerland each reported 5.

In 2018, the Centers for Disease Control (CDC) calculated the US maternal mortality rate at 17.4 deaths per 100,000 live births. The agency had not previously published the indicator since 2007 due to efforts aimed at ensuring consistent death certificate pregnancy reporting at the state level. According to the CDC, 658 women died of maternity-related causes in 2018, with American Indian, Alaskan Native, and African-American populations among those most frequently impacted. Native groups collectively experienced a mortality rate of 43.6 deaths per 100,000 live births in 2019, while African-Americans suffered 37.1 deaths per 100,000 in 2018.

The rate for African-Americans was 2.5 times that of White women (14.8), and 3.1 times that of Hispanic women (11.8). Over the past 60 years, the risk of maternal mortality among Black women has consistently remained about 3–4 times higher than the equivalent risk for White women. For women of all races, the risk of maternal death predictably increases with age. This risk is further highlighted by the average age of women during first birth also steadily increasing from 1990 to 2012.Women 35–39 are about twice as likely to suffer maternal mortality than those age 20–24, while women over 40 face an even higher risk of dying.

Underlying Population Health Challenges

Social determinants of health are major factors underlying higher incidence of maternal mortality among women of color. Women living in middle- to high-poverty areas face a 60% and 100% greater risk of maternal-related death than women living in low-poverty areas. Among Black and Hispanic populations, the proportion of those living below the poverty rate is more than twice that of Whites (22% and 19%, respectively, compared to 9% for Whites); among Natives, the percentage living in poverty (26%) is nearly 3 times that of Whites.

Poverty contributes to a lack of health insurance and reduced access to high-quality healthcare services, including information on reproductive health. In 2017, the uninsured rate was 24.4% for Hispanic new mothers, 12.1% for Black new mothers, and 7% for White new mothers. Women who receive no prenatal care are 3–4 times more likely to have a pregnancy-related death than women who do.

Barriers to appropriate care, including lack of insurance, also contribute to higher rates of comorbidities among pregnant women of color, who rank substantially lower than White women on a range of key health indicators, including diabetes, obesity, heart disease, and hypertension. Overall, cardiovascular disease is the leading cause of postpartum death among American women.

Research further suggests that the cumulative stress associated with systemic racism and early childhood trauma can contribute to poor perinatal outcomes. The term “weathering” has been developed to describe the early health deterioration Blacks experience due to long-term social and economic adversity and accompanying political marginalization. The phenomenon is believed to contribute to high maternal mortality rates, making pregnancy riskier at an earlier age.

Contributing Risk Factors Across the Maternity Care Continuum

According to the CDC, maternal mortality events occur in nearly equal proportion across the childbearing continuum, with 31% of deaths taking place during the 40-week prenatal period, 36% during delivery or within a week after birth, and 33% between 1 week and 1 year postpartum (Figure 1).

Figure 1. Percentage of Maternal Deaths Across the Maternity Care Continuum, 2019

Created from data from CDC Vital Signs, May 2019

Understanding the predominant risks present for women of color during each stage of pregnancy is essential for developing comprehensive, integrated population health programs and interventions to reduce maternal mortality.

Figure 2. Maternal Mortality Risk by Stage of Pregnancy

Source: VeryWellFamily, Maternal Mortality Rate, Causes, and Prevention, June 5, 2019

Key Recommendations for Reducing Maternal Mortality Among Women of Color

Closer patient monitoring and engagement across the maternity care continuum, improved patient education, standardized emergency protocols, quality measures supported by value-based reimbursement, and the extension of care in the postpartum period represent some of the tools available to reduce US maternal mortality rates. Payers, providers, and other healthcare stakeholders looking to improve maternal outcomes should consider developing or implementing various strategies such as:

• Preconception health counseling helps women better understand their pre-existing health conditions and the potential risk factors that could negatively impact a pregnancy. These visits give clinicians the opportunity to discuss family history, medical conditions, lifestyle decisions, and medication use with women who are considering getting pregnant. Important clinical recommendations can be made to help ensure that women are aware of what to do before and between pregnancies to increase the chances of having a healthy delivery and baby. In 2019, the American College of Obstetricians and Gynecologists (ACOG) released new guidance after concluding physicians were missing opportunities to identify risk factors prior to pregnancy. The ACOG also determined that delays often occurred in recognizing symptoms during pregnancy and postpartum, particularly for Black patients. According to the 2019 guidance, patients should see a cardiologist prior to pregnancy and receive pre-pregnancy counseling. If they are determined to be at moderate or high risk, cardiovascular disease should be managed during pregnancy, delivery, and postpartum in a medical center capable of providing a high level of care. A follow-up visit with a primary care clinician or cardiologist should occur within 7–10 days of delivery for all women with hypertensive disorders and 7–14 days for all women with heart disease or cardiovascular disorders.
• SDM is a process that enables clinicians and women to make decisions and plan care together based on a balance between clinical evidence, patient risk, and patient preferences. During the course of a pregnancy, SDM discussions may help doctors and patients make care and delivery decisions that could reduce the chance of complications and death. To address site-of-delivery hazards, the ACOG recommends SDM discussions with expectant women that include information about the risks associated with home birth for both mother and baby, as well as absolute contraindications for home birthing, including fetal malpresentation, multiple gestation, or prior cesarean delivery. Payers may want to consider leveraging provider networks, clinical care teams, and care navigators to support and influence patient decisions around maternal care.
• Quality measurement can improve healthcare quality, increase provider accountability, and identify the misuse of health services. While some quality measures have been endorsed and implemented for perinatal and reproductive health, the development of more accurate and appropriate measures related to pregnancy and delivery is needed. Once created, widespread use of maternal mortality quality measures will be necessary to increase awareness of various potential complications. Eventually tying physician performance on the measures to reimbursement will be another step to help ensure quality improvement for birthing mothers. Payers can enable greater prenatal and postpartum outreach from quality management and performance improvement teams focused on closing gaps in care, with particular focus on Healthcare Effectiveness Data and Information Set measures tied to better maternal outcomes such as the Prenatal and Postpartum Care measures.
• Postpartum assessments for all women within the first 3 weeks following birth can help address issues related to poor postpartum outcomes. Ongoing care should be provided as necessary, along with a final, comprehensive postpartum visit occurring no later than 12 weeks after birth. One way to ensure more women receive these assessments is to extend Medicaid coverage in the postpartum period beyond the currently required 60 days. Home health visits for postpartum mothers would similarly increase access to postpartum care and reduce the likelihood of postpartum complications, especially for women that may struggle with issues of social support, transportation, and maternity leave. Some payers have developed incentive or intervention programs focused on improving the rates of postpartum follow-up visits to enhance maternal and child health outcomes. These strategies include distribution of postpartum care education brochures and community resources, as well as the use of obstetrics care managers monitoring high-risk women with individualized care plans.
• Standardized obstetric emergency protocols based on evidence-based guidelines could reduce potentially dangerous variances in care. Insofar as over half of pregnancy-related deaths are preventable, better systems are needed to prevent or reduce the severity of emergencies that arise during delivery. The ACOG encourages clinicians to assess potential emergencies, establish early warning systems, designate specialized first responders, conduct emergency drills, and debrief staff after actual events to identify strengths and opportunities for improvement. These protocols are typically developed by individual facilities, but it may be more beneficial for minimum standards to be mandated at the state or national level.

Maternal Mortality Illuminates a Wider Problem

While it’s true the absolute number of US mothers lost annually due to maternity-related causes is relatively small, the repercussions of these deaths for surviving loved ones, particularly children, are enormous and ongoing. Moreover, maternal mortality statistics are merely the most visible indicator of a much deeper public health problem: For every maternal death, more than 100 women experience severe maternal morbidity, a life-threatening diagnosis, or a life-saving procedure during delivery hospitalization.

A comprehensive approach to reducing maternal mortality that integrates patient education, clinical improvements, and care standardization across the maternity care continuum could have a substantial impact on the rate of birth-related deaths and the morbidities that contribute to them among women of color.

To learn more about Avalere’s work in this space, connect with us

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Transcription:

Jasmine Nicole: Hello and welcome to the first episode in the Avalere Health Essential Voice series focused on the findings and themes from Avalere’s journal club. In this series, we will provide commentary on a contemporary healthcare publication presented at an internal journal club meeting in May. Avalere hosts a monthly journal club to critically assess newly released studies in terms of its methods and analyses and discuss how the findings can be applied to our work.

My name is Jasmine Nicole Namata and I am an Associate here at Avalere. Joining me today is Courtney Ramus, a Consultant in the Center for Healthcare Transformation. Courtney has a background in patient engagement, shared decision making, and health disparities.

In today’s episode, we will be debriefing on the article titled “Understanding of Key Obstetric Quality Terminology by Asian and Pacific Islander Subgroups: Implications for Patient Engagement and Health Equity” by Mary Guo published in the Maternal and Child Health Journal in 2018.

To kick us off, the goal of this study was to consider whether commonly used childbirth related health quality terms were understandable to diverse women, including Asian American and Pacific Islander (AAPI) subgroups, and how comprehension varied by relevant factors, such as health literacy, education, race, and ethnicity. The researchers sought to answer the question of: “Amongst AAPI women who had recently given birth, what is their comprehension level of 10 common obstetric terms?” The study highlights the important role that comprehension of quality terminology plays for patient engagement across diverse populations, specifically in maternal care.

For background, the authors note that 30% of Asian Americans are likely to have low health literacy compared to white Americans, with a low health literacy level of 16%. The authors also note that 44% of the Asian Americans who have limited English proficiency are also likely to report low health literacy. This is concerning because gaps in health literacy can disproportionately affect these minority groups and those with lower socioeconomic status more drastically. However, while there is growing work that investigates health literacy and various health conditions, AAPI subgroups are often underrepresented or limited in research, especially in women’s reproductive health.

In the methods section of the article, it details the mixed-method interviews that were conducted with women in Hawaii who had a recent childbirth. To determine their use of healthcare quality information, researchers recruited for about 2 years—from July 2013 to July 2015—and had specific inclusion and exclusion criteria for participants. Among those who qualified, demographic data was collected. In the interview, participants were asked to read out loud and explain the meaning of 10 obstetric quality terms. And participants were also assessed for their subjective health literacy and objective health literacy through a validated question and Rapid Estimate of Adult Literacy in Medicine (REALM) Health Literacy Test tool, respectively.

Through this study, it uncovered a range of understanding of key obstetric terms amongst study participants. Words like breastfeeding and Cesarean section (C-section) were commonly understood but other words like primary C-section were not understood. And even some words like episiotomy and VBAC (vaginal birth after cesarean) were not well known or understood among the participants, despite the impacts these could have on their health. The article also found that comprehension of obstetric terms varied amongst AAPI subgroup participants. Those who identified as Filipino, Japanese, Native Hawaiian, or Pacific Islander, as well as having low objective health literacy and only having a high school degree were significantly associated with less total comprehension.

Lastly, the author postulates that comprehension of quality terminology has the potential to improve patient engagement. Without knowledge of critical terminology, it can be challenging for patients to be engaged participants who seek and demand high quality maternity care. To pivot, Courtney, you have done a lot of work in healthcare quality measurement and have conducted research in quality improvement. What is quality terminology and how is it used?

Courtney: Broadly, quality terminology refers to terms that are associated with high-quality care in a particular area, such as maternity care, cancer care, inpatient care management, or medication safety. These terms are commonly used in patient-provider interactions and commonly referenced with regards to treatment or treatment-related decisions. For example, some of the terms assessed in the article were episiotomy and C-section because rates of episiotomy and C-section are commonly referenced during maternity care.

Quality terms are not only commonly referred to during maternity care, but also commonly used to assess quality of care within a particular setting. So, with C-section, rate of C-section within a hospital is commonly assessed as a marker for high-quality care. Hospitals that are below a threshold for percentage of births that are C-section are considered to meet standards for quality maternity care.

As noted in the article, patients can use hospital quality reports to assess which hospital to seek treatment within. These reports may be released by state or federal government or other private organizations like The Leapfrog Group. Patients can review online reports for hospitals in their area to see how they “rank” for certain quality metrics. For example, if a pregnant woman in California wanted to determine which hospital to give birth in, she could go to calhospitalcompare.org to compare how hospitals near her perform on maternity-related metrics such as C-section or episiotomy to make an informed decision on where to seek her maternity care. However, if consumers like the women in California are not aware of or have never heard of such terminology, it is hard to use public reports to decide which hospitals have the best quality of care.

Quality terminology is used by multiple stakeholders, including patients, providers, hospitals, and payers. The article was really focused on patient comprehension of quality terminology and patient engagement with hospital quality information.

Jasmine Nicole: That is interesting. Your point about patient comprehension of quality terminology brings up an important point in ensuring we define literacy and health literacy. To level set with our listeners, health literacy is defined by the US Department of Health and Human Services (HHS), as “the degree to which individuals have the capacity to obtain, process, and understand basic health information needed to make appropriate health decisions”. And gaps in health literacy are a major public health issue. For example, back in 2004, the Institute of Medicine (IOM) reported that health literacy is critical to improving health of individuals in the nation. In 2006, the US Department of Education released the first national assessment of health literacy in English speaking adults. The report found that only 12% of English-speaking adults in the US have proficient health literacy, which means 9 out of 10 English speakers have comprehension issues for their own health. This prompted HHS in 2010 to release the National Action Plan to Improve Health Literacy. It outlined strategies and goals to pursue to meet Healthy People 2020 objectives. Courtney, can you speak to some of the impacts of low health literacy on healthcare decision making?

Courtney: As you mentioned, we know comprehension issues are common among groups with disparities, including low health literacy. I liken this to going to a restaurant in a country where you do not speak the language. You are handed a menu in another language and probably spend some time reading over it to try to understand what to order. You may even ask the waiter/waitress for help, but because you do not speak the same language, you may not get the answers you are looking for or find the exchange to be useful. You might order something that looks or sounds kind of familiar, recognizing a word or a root of a word. However, you may end up choosing something you would have never selected had you fully understood when you ordered. I find this to be a relatable analogy when describing some of the cultural and linguistic barriers to accessing healthcare information for patients with low health literacy or even patients who do not speak English as a first language.

The authors in the article noted that pregnant women typically know they will be hospitalized at the time of their delivery and have a strong interest in factors that will impact their birthing experience. However, women with low health literacy are less likely to feel they can have an impact on their birthing outcome, and instead rely on their healthcare provider to be in control of their outcomes.

Unfortunately, we know that this issue is not unique to obstetric care. For example, I do a lot of work with patients with cancer. We often hear from those patients that they felt extremely overwhelmed when they were first diagnosed, both by the diagnosis itself, but also the pressure to take in a lot of new information and terminology and make decisions quickly. Patients who may be less empowered to ask questions or express their preferences end up deferring to their provider to make early treatment-related decisions.

Jasmine Nicole: That is a great analogy, Courtney! You brought up important points. The article acknowledges that AAPI subgroups in the US have known disparities in healthcare quality and access but again it is limited and underrepresented, specifically as it relates to health literacy and women’s health. The article did assess comprehension of 10 common obstetric terms amongst AAPI women and researchers found that health disparities in obstetric trauma for some of these ethnic populations is more prevalent than others, making comprehension of this term relevant. For patients to make decisions on their health, they have to be able to effectively communicate with their physician and articulate their needs. From your perspective, what are the implications of gaps in comprehension on healthcare decision-making?

Courtney: As you mentioned, one of the main findings of the article was that for some of the quality terms, there was not just a lack of understanding, but a misunderstanding of the term. For example, with the term obstetric trauma, women perceived the term to be related to something akin to post-traumatic stress disorder or fear after giving birth. This finding has broader implications for treatment adherence and chronic-disease management. If patients do not fully understand or misunderstand terminology as they are making healthcare-related decisions, they cannot make fully informed decisions. This problem is referred to as the healthcare decision-making paradox, where there is this increased demand on patients to support healthcare-related decisions, but it is not accompanied by the appropriate information or understanding of information to make informed decisions.

In the context of healthcare quality reports, misunderstanding of health messages or quality terminology may render these reports to be not particularly useful or even harmful to the patient.

Jasmine Nicole: Thank you, Courtney. The authors do describe a need for improved communication between healthcare providers and patients to ensure understanding and equity in healthcare quality terminology engagement. This study is adding to the body of literature supporting the need for effective patient education and provider-patient communication. Courtney, what are some tools to solve the healthcare decision-making paradox and support patients who have limited health literacy?

Courtney: There is a lot of traditional patient education work being done to support improved health literacy. The authors note the use of web-based pregnancy applications that allow for personalization, monitoring, and frequent use by patients that look promising. To ensure these solutions are helpful, it is important that they be written at the appropriate literacy level. For example, the American Medical Association and National Institutes of Health recommend patient education materials be written at a 6^th grade or below reading level. The Joint Commission recommends a 5^th grade or below reading level. It is also important that those who are developing materials or applications understand health literacy and its importance.

Similarly, for hospital quality reports, there are opportunities to ensure that key quality terminology is defined at the appropriate literacy level within the quality report itself. A lot of these reports allow the patient or consumer to hover or click on the metrics, to read a description. For example, I looked at a report where I was able to click on the term “episiotomy” to see that it noted, “Episiotomies have been clearly linked with worse perineal tears, loss of bladder or bowel control, and pelvic floor defects.” Terms like “perineal tear” or “pelvic floor defects” are not defined in the report and may not be familiar to everyone reading them.

To help with the decision-making paradox, I mentioned before that I do a lot of work with cancer patients. We see very similar challenges in this population, with respect to patients having some understanding of what their treatment and disease management may look like, but frequently not having a full understanding of what their experience may be in the next 1-, 3-, 5 years as well as patients having challenges understanding the terminology to support decision making and navigate the various settings of care. Cancer patients we work with expressed a desire to have material that helps them to organize their thoughts shortly after diagnosis, understand what to expect in their care experience, and communicate their preferences with their oncologist.

To support this need, we applied a human-centered design approach to develop preparation for shared decision-making tools for both breast cancer and non-small cell lung cancer patients. Evidence strongly supports involving members of the target audience in the design and testing of communication products and is suggested as a method to improve health literacy in the National Health Literacy Action Plan.

The tools we finalized allow patients to communicate preferences around decision making with their oncologist ahead of making any treatment-related decisions. For example, some patients prefer to know everything there is to know, while others prefer the provider recommend a course of action. It is important for the patient to decide where they are on that spectrum to be able to appropriately communicate that with their healthcare provider. We have found that patients are very receptive and excited by the idea of a receiving a tool like this, shortly after diagnosis. Similarly, we find that oncology healthcare providers really want to have these types of discussions with their patients to help their patient to make the best decision for themselves.

When these communication barriers are broken down between the patient and provider and the provider has a better understanding of the patient as a person, there is tremendous opportunity for informed, equitable treatment-related decision making.

Jasmine Nicole: Wow! Thank you, Courtney. Thank you for joining me today. Your insights have been extremely valuable to our listeners. Thank you for tuning into Journal Club Review on Avalere Health Essential Voice. Please stay tuned for more episodes. If you would like to learn more, please visit us at our website www.avalere.com.

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USPSTF recommends that primary care clinicians assess women with a personal or family history of breast, ovarian, tubal, or peritoneal cancer or who have an ancestry associated with breast cancer susceptibility 1 and 2 (BRCA1/2) gene mutations with an appropriate brief familial risk assessment tool (“B Grade”). Women with a positive result on the risk assessment tool should receive genetic counseling and, if indicated from counseling, genetic testing. The task force does not recommend these services for women who have never been diagnosed with breast cancer or whose personal or family history is not associated with potential harmful BRCA1/2 gene mutations (“D Grade”).

Mutations in BRCA1 and BRCA2 increase the risk for breast, ovarian, fallopian tube, and peritoneal cancer in women, breast cancer in men, and, to a lesser degree, pancreatic and early-onset prostate cancer. Moreover, these mutations occur in 1 in 300 to 500 individuals in the general population and are more common among Ashkenazi Jewish and Hispanic populations. Interventions to reduce risk for cancer in mutation carriers include earlier and more frequent cancer screenings, risk-reducing medications, and risk-reducing surgeries.

In tandem with the recommendations for risk assessment and genetic counseling for BRCA 1/2, the task force also expanded their recommendations for prescription of risk-reducing medications. The USPSTF recommended (“B Grade”) that clinicians offer to prescribe risk-reducing medications (e.g., tamoxifen, raloxifene, aromatase inhibitors) to women at an increased risk for breast cancer who are asymptomatic and have never had a breast cancer diagnosis. The task force does not recommend these services for women who are not at increased risk (“D Grade”).

While USPSTF’s recommendations were broadened to include a wider screening-eligible population and more risk-reducing medications, the path forward for stakeholders may be unclear.

Avalere has identified 4 key takeaways for understanding the impact of USPSTF’s recommendations:

1. The 2019 recommendation for BRCA-related cancers differs from the 2013 recommendation in that the screening-eligible population now includes those with a personal cancer history and with ancestry linked to BRCA1/2 mutations.
2. With a “B Grade” recommendations from the task force, Medicaid expansion programs and commercial health plans must offer these services with no cost sharing to women specified. However, with a “D Grade,” health plans do not have to offer these services to women are not included in the screening populations and may impose cost sharing if they are prescribed.
3. When appropriately used, genetic counseling reduces anxiety and depression, increases understanding of risk, and reduces interest in unauthenticated genetic testing. However, the ability of risk assessment, testing, and counseling to reduce cancer incidence and mortality among women has not been directly evaluated by studies to date.
4. Though not specifically mentioned by the USPSTF, discovering a BRCA mutation has important implications for treatment. Poly (ADP-ribose) polymerase (PARP) inhibitors have shown success in patients with BRCA-driven cancers.

Currently, there are no specific recommendations for men or for individuals of a particular ancestry. As research and awareness about BRCA-related cancers continues to grow, it is likely that USPSTF will update their recommendations accordingly in coming years.

To learn more about Avalere’s capabilities in this area, connect with us.

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In 2019, Avalere validated the tool for its usability and acceptability (i.e., comprehensibility, amount of information, and suitability for decision-making) through surveys and in-depth interviews with 30 women with stages III and IV advanced breast cancer. The table below describes the diverse population of women with whom we worked.

In the chart pack, we present a summary of the results from our surveys. The survey data demonstrate that 90–100% of surveyed patients found the tool understandable, valuable, containing the right amount of information, and useful in preparing them for decision-making conversations with their doctors. All 30 patients agreed that they “value the guidance provided in this tool.” The full validation study—informed by the qualitative data from our interviews—will be analyzed and published separately.

Learn more about the tool and its development process.

In addition to developing and validating the Preparation for Shared Decision Making tool, Avalere also developed consensus-based recommendations to advance the patient centricity of value assessment frameworks. These recommendations will be released tomorrow, May 30.

To receive Avalere updates, connect with us.

The post Testing Proves Usefulness of Avalere Shared Decision-Making Tool to Women with Advanced Breast Cancer appeared first on Avalere Health Advisory.

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Given the varying recommendations, clinicians play a crucial role in conveying key messages on benefits and harms of breast cancer screening and engaging patients in shared decision-making.

For more information on breast cancer screening recommendations and their potential impact on patients’ access to mammography, contact Minnie Song at msong@avalere.com.

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