Barriers to early detection: Insurance denials for breast MRI screening in women with germline BRCA1/2 mutations

Abstract

Objectives:

Women with germline BRCA1/2 pathogenic variants (gBRCA1/2) are recommended to undergo annual breast MRI and mammography. Our objective was to describe the frequency of insurance denials for annual breast MRIs in women with gBRCA1/2 and determine denial trends.

Methods:

Women with gBRCA1/2 following in a high-risk breast cancer clinic with breast MRIs ordered from 2020–2021 were identified and cross-referenced with a database of insurance denials. Radiology records were queried to determine if screening breast MRIs were performed in 2020 and 2021. Rates of MRI denials and outcomes after appeal were determined.

Results:

There were 682 women with gBRCA1/2 who had screening breast MRIs ordered from 2020–2021, including 318 (47%) BRCA1, 356 (52%) BRCA2, and 8 (1%) with both. 73 women (11%) had an MRI denied. Women insured through Medicaid had the highest rates of denials (2020: 7%, 2021: 18%), followed by commercial insurance (2020: 6%, 2021: 9%). There were significantly more denials in 2021 compared to 2020 (p=0.044), and 2021 denials were more likely to be denied on appeal. Of women with denials, 4 (14%) in 2020 and 5 (11%) in 2021 did not have a screening MRI performed. One patient with DCIS had an MRI denial prior to diagnosis.

Conclusion:

Breast MRI insurance denials were present in 11% of this high-risk cohort, and 14% of women with denials did not undergo annual screening. There were significantly more denials in 2021, suggesting worsening barriers for these patients and added burden on providers to appeal for appropriate screening tests.

Introduction

The lifetime risk of developing breast cancer among average risk American women is 13% in the population, though it is significantly greater for individuals with a germline BRCA1/2 pathogenic variants (gBRCA1/2). For individuals with BRCA1, lifetime breast cancer risk is up to an estimated 67%, while it is 49% for patients with BRCA2.[1,2] Over the past three decades, genetic testing for gBRCA1/2 has become increasingly widespread,[3] which has improved patient autonomy and facilitated risk-reducing measures for these at-risk individuals.

The National Comprehensive Cancer Network (NCCN) recommends that patients with gBRCA1/2 complete annual screening for breast cancer with breast MRIs from ages 25–29 and both annual mammograms and breast MRIs from ages 30–75.[4,5] MRI has greater sensitivity for detecting breast cancer and is more effective at detecting cancer at earlier stages compared with mammography, making annual breast MRIs imperative for these high-risk patients.[6–8] While the USPSTF is in the process of updating recommendations for patients with BRCA-related cancer, the organization does not explicitly outline guidelines for screening for patients with gBRCA1/2.[9] [10] Additionally, the Affordable Care Act mandates that all marketplace insurance plans cover genetic testing for women at high risk for breast cancer as well as mammography screenings every two years for women over 50 and as recommended for women over 40.[11] Yet, this mandate does not extend to all types of insurance plans, nor does it include specifications on coverage for enhanced breast screening for high-risk individuals.[12]

Prior research demonstrates inconsistencies in the insurance landscape surrounding genetic testing for gBRCA1/2 as well as the provision of risk-reducing services even after patients obtain identification of a pathogenic variant through genetic testing. Although it is widely established that annual breast MRI is the standard for screening patients with gBRCA1/2, this recommendation does not always translate into practice. As such, the objective of this study was to describe the patterns of denials for prior authorizations as well as insurance claims for annual breast MRIs that providers ordered to screen patients with gBRCA1/2 for breast cancer and to determine recent trends in denial over time.

Methods

All unaffected women with gBRCA1/2 receiving care in a specialized high-risk breast cancer surveillance clinic based at the Memorial Sloan Kettering Cancer Center (MSKCC) in New York City whose providers had ordered breast MRIs between January 1, 2020 and December 31, 2021 were included in this study. Patients with a prior diagnosis of breast cancer were excluded. A database of insurance denials was cross-referenced to identify patients that received denials for breast MRIs. Radiology records were extracted through chart review to confirm whether patients included in this study underwent the screening breast MRIs that their providers had ordered for them. Rates of MRI denials as well as outcome after appeals were determined, and these rates were compared by year. Finally, the rationale for denial was determined through assessing financial services records.

Results

682 women with gBRCA1/2 whose providers had ordered screening breast MRIs from 2020–2021 were identified. General patient demographics are shown in Table 1. 318 (47%) patients had germline BRCA1 pathogenic variants, 356 (52%) patients had germline BRCA2 pathogenic variants, and 8 (1%) patients had both germline BRCA1 and BRCA2 pathogenic variants. 73 (11%) patients had insurance denials for screening breast MRI. There was a significant difference (P < 0.01) in the ages of women who experienced denials (median 38 years, IQR 25–65) compared with those who did not (median 44 years, IQR 24–79). For patients with Medicaid, the rates of denials were 7% in 2020 and 18% in 2021. For patients with commercial insurance, the rates of denials were 6% in 2020 and 9% in 2021. Patients who had Medicare did not experience any denials (Table 2).

Table 1:

Patient demographics of patients with gBRCA1/2 ordered for screening breast MRIs

Characteristic	Patients (n=682)
Age, mean (SD)	47.8 (15.9
Race
Asian	30
Black/African American	14
White	604
Other	19
Unknown	15
Ethnicity
Hispanic/latinx	27
Non-Hispanic/latinx	623
Unknown	32
Deleterious mutation, n, (%)
BRCA1	318 (47)
BRCA2	356 (52)
Both	8 (1)
Breast pathology, n, (%)
Underwent biopsy	17 (2.5)
Pre-cancer diagnosis	5 (0.7)
Cancer diagnosis	12 (1.8)

Table 2:

Breast MRI claim status by insurance type for patients with gBRCA1/2

	2020			2021
	Approved, n, (%)	Denied, n, (%)	Total claims, n=558	Approved, n, (%)	Denied, n, (%)	Total claims, n=532
Medicaid	14 (93)	1 (7)	15	14 (82)	3 (18)	14
Medicare	67 (100)	0 (0)	67	67 (100)	0 (0)	67
Commercial	477 (94)	28 (6)	477	451 (91)	42 (9)	451

When stratified by year (Table 3), 543 and 533 breast MRIs were ordered for patients with gBRCA1/2 in 2020 and 2021 respectively. In 2020, 29 (6%) MRIs were denied. After appeal, 8 (28%) of these MRIs were denied and 21 (72%) were approved. In 2021, 45 (8%) breast MRIs were denied. After appeal, 23 (51%) were denied, and 22 (49%) were approved. There was a significant difference in denials of breast MRIs in 2020 compared with 2021 (p = 0.044), and denials were also more likely to be denied after appeal (p=0.045). Of women who experienced denials, 4 (14%) and 5 (11%) women in 2020 and 2021 respectively did not complete a screening MRI.

Table 3:

Breast MRI claim status after appeals process for patients with gBRCA1/2

	2020			2021			p value
	Approved, n, (%)	Denied, n, (%)	Total, n	Approved, n, (%)	Denied, n, (%)	Total, n
All claims	514 (95)	29 (5)	543	488 (92)	45 (8)	533	0.044
Appealed claims	21 (72)	8 (28)	29	22 (49)	23 (51)	52	0.045
Denied Claims	MRI completed, n, (%)	MRI not completed, n, (%)	Total, n	MRI completed, n, (%)	MRI not completed, n, (%)	Total, n
	25 (86)	4 (14)	29	40 (89)	5 (11)	45	0.73

Of patients who underwent screening MRI, 17 (2.5%) women had breast pathology diagnosed during the study period. 12 (1.8%) patients had invasive carcinoma, and 5 (0.7%) patients had ductal carcinoma in situ (DCIS). One (0.7%) patient who was diagnosed with DCIS had experienced a denial for a screening breast MRI prior to diagnosis.

Finally, through evaluating financial services records, we determined that the primary reasons why insurance companies denied prior authorizations for breast MRIs were the following: there was an authorization for a similar study on file (14); clinician records did not sufficiently demonstrate medical necessity (13); the study was ordered outside the approved timeframe (7); the study involved repeat imaging (2); and rationale in clinical records did not meet guidelines (2). The reasons for the denial were not specified in the remaining financial services records. All denials were appealed by the financial office at this institution.

Discussion

While screening breast MRIs are clinically indicated for patients with gBRCA1/2, our findings demonstrate that insurance denials occurred for up to 11% of patients. After patients received denials, 14% of these patients ultimately did not undergo annual screening in 2020. Additionally, significantly more patients received denials even after pursuing the appeals process in 2021 compared with 2020. This increase suggests that barriers for undergoing their recommended annual screening worsened for these-at risk patients, further placing the onus on patients and providers to pursue appeals to obtain warranted health maintenance services.

The landscape surrounding insurance reimbursement for genetic and preventative services for patients who are at risk for hereditary cancer is opaque. For example, Wang et al. evaluated gBRCA1/2 coverage policies for large private and public payors in 17 states and specifically looked at eligibility criteria for genetic testing, genetic counseling, and screening MRIs.[13] Most private payors did not have explicit coverage policies for genetic testing and screening MRIs when compared with public insurers, and there were no policies regarding breast screening MRIs. Our findings similarly demonstrated that Medicare provides the most comprehensive coverage for screening MRIs, as none of the 67 patients in 2020 or 2021 faced denials while patients with both Medicaid and commercial insurance did.

In light of disparate insurance policies, patients with gBRCA1/2 experience significant barriers in accessing appropriate services to prevent breast and gynecologic cancer. These barriers are pervasive along the spectrum of preventative care services for this patient population. A retrospective study by Olaya et al. showed that patients who were at high risk for breast cancer were more likely to undergo genetic testing for gBRCA1/2 at a breast health center if they had insurance coverage.[14] In Michigan, Hayden et al. surveyed facilities offering genetic counseling services. 32.2% of patients referred to these centers who did not ultimately undergo genetic testing named out-of-pocket costs and limited insurance coverage as the most common non-medical reason for why they chose not to undergo testing, regardless of whether they had public or private insurance.[15] Other studies have similarly shown that insurance coverage even precludes patients without a genetic diagnosis from accessing routine annual mammography screening.[15,16]

Insurance policies are similarly variable for prophylactic mastectomies for patients with gBRCA1/2. In a cross-sectional evaluation of 100 of the largest third-party payors in the United States, Ha et al. provided the most comprehensive survey of insurance coverage for prophylactic mastectomies, and just half of all payors had explicit policies surrounding eligibility criteria prophylactic mastectomies.[17] Some payors covered on a strictly case-by-case basis, while provision of coverage was also contingent on other factors ranging from a personal history of breast cancer to prior radiotherapy.

Socioeconomic barriers, including race and insurance status, were also notable for a variety of services ranging from genetic testing to contralateral prophylactic mastectomy.[18][15] These limitations extend to other types of cancers, as patients with Medicaid are 25% less likely to receive guideline-concordant care for gynecologic cancer.[19] Additionally, insurance plans administered by managed Medicaid payors likely contributed to the relatively high proportion of denials in this particular patient population compared with Medicare plans. As our study evaluated patients who already had a formal diagnosis of a deleterious mutation and were able to access services at an urban referral-based cancer center, access to these preventative services may be even more limited for patients in rural or suburban regions. Even at this specialty clinic at our institution, 14% of patients who experienced a denial for their annual breast MRI did not ultimately receive an MRI in 2020, and one of these patients later had a diagnosis of ductal carcinoma in situ (DCIS). This lapse in care underscores how a convoluted insurance appeals process directly confers a risk of delayed diagnosis even for patients who have proactively sought out these services.

This study has several strengths. To our knowledge, this is the first study to evaluate insurance coverage for screening MRIs for patients at risk for BRCA-associated breast cancer. Additionally, we utilized both hospital electronic medical records as well as insurance claims data to corroborate insurance coverage and denials for patients included in the study. This study also has several limitations. First, this study was conducted in a single urban academic institution. As such, our findings are specific to this particular patient population who sought care at a quaternary referral center and may not reflect the experience of other patients who seek care for breast cancer screening in other settings. For example, larger institutions such as this one may have additional resources to pursue the appeals process in comparison to smaller community centers. Next, this study focused exclusively on the impact of insurance denials on completing high-risk screening, though barriers to completing MRI screening may be multifactorial. Additionally, while this study captures the insurance coverage landscape for breast MRIs for patients with gBRCA1/2, recommendations for breast cancer screening for other deleterious mutations typically do not follow discrete guidelines. As such, evaluating insurance coverage for breast cancer screening modalities for these patients requires further investigation. Finally, our study period was limited to a two-year time frame. Future studies are needed to better understand longitudinal trends in insurance coverage for breast MRIs and other preventative care measures for patients with gBRCA1/2 as well the provision of services for patients with other deleterious mutations.

Despite clear guidelines for annual breast surveillance for patients with gBRCA1/2, insurance coverage for breast MRIs was variable depending on insurance type and year. Limitations in insurance coverage precluded some patients from receiving their annual screening breast MRI, which may increase the risk of delayed diagnosis for breast cancer. Larger studies are needed to better understand the national landscape of insurance coverage and denials for breast MRIs and other health maintenance services for patients with gBRCA1/2 as well as other deleterious mutations.[20] The implementation of Senate Bill S2465C in New York, which was enacted in October 2024 and mandates insurance coverage for supplemental breast cancer screening per national guidelines, will hopefully address these gaps in care for the patient population included in this study. Ultimately, increased transparency in insurance policies is paramount for ensuring that these high-risk patients receive the standard of care for breast cancer surveillance.