Original Research

Regional and racial disparities in major amputation rates among medicare beneficiaries with diabetes: a retrospective study in the southeastern USA

Abstract

Objective While rates for non-traumatic lower extremity amputations (LEA) have been declining, concerns exist over disparities. Our objectives are to track major LEA (MLEA) rates over time among Medicare beneficiaries residing in a high diabetes prevalence region in the southeastern USA (the diabetes belt) and surrounding areas.

Methods We used Medicare claims files for ~900 000 fee-for-service beneficiaries aged ≥65 years in 2006–2015 to track MLEA rates per 1000 patients with diabetes. We additionally conducted a cross-sectional analysis of data for 2015 to compare regional and racial disparities in major amputation risks after adjusting for demographic, socioeconomic, access-to-care and foot complications and other health factors. The Centers for Disease Control and Prevention defined the diabetes belt as 644 counties across Appalachian and southeastern US counties with high prevalence.

Results MLEA rates were 3.9 per 1000 in the Belt compared with 2.8 in the surrounding counties in 2006 and decreased to 2.3 and 1.6 in 2015. Non-Hispanic black patients had 8.5 and 6.9 MLEAs per 1000 in 2006 and 4.8 and 3.5 in 2015 in the Belt and surrounding counties, respectively, while the rates were similar for non-Hispanic white patients in the two areas. Although amputation rates declined rapidly in both areas, non-Hispanic black patients in the Belt consistently had >3 times higher rates than non-Hispanic whites in the Belt. After adjusting for patient demographics, foot complications and healthcare access, non-Hispanic blacks in the Belt had about twice higher odds of MLEAs compared with non-Hispanic whites in the surrounding areas.

Discussion Our data show persistent disparities in major amputation rates between the diabetes belt and surrounding counties. Racial disparities were much larger in the Belt. Targeted policies to prevent MLEAs among non-Hispanic black patients are needed to reduce persistent disparities in the Belt.

What is already known on this topic

  • Patients with diabetes are at a risk of foot complications including major lower extremity amputations. Black patients and patients living in rural areas have been shown to have higher rates of major amputations. Major amputation disparities have not been assessed within a rural southeastern US area with high diabetes prevalence named the diabetes belt.

What this study adds

  • Our study highlights that there are persistent racial and geographical disparities in the diabetes belt compared with surrounding areas.

How this study might affect research, practice or policy

  • This study highlights the need for policies to prevent major amputations among black patients, particularly in the diabetes belt where there are disparities compared with the surrounding areas.

Introduction

Patients with diabetes are at an increased risk of foot ulcers and non-traumatic lower extremity amputations (LEAs) due to factors including poor glycaemic control, peripheral neuropathy and peripheral arterial disease.1 Previous studies showed that black patients with diabetes are more likely to present with more advanced disease than white patients, contributing to considerably higher risks of LEAs.2–7 Patients living in rural areas have higher rates of LEA.4 8 Emerging data suggest that LEA disparities are amplified when these two social determinants of health—race and rurality—overlap.9 10 Nearly all rural counties with black majorities are located in the Southeastern USA.11 This same geographical area contains the diabetes belt, a high diabetes prevalence region identified by the Centers for Disease Control and Prevention (CDC) with higher rates of diabetes.12 While this area was identified with the data that go back to 2007 and 2008, this area is still very much relevant for health policy as evidenced by the continued attention to this area by the CDC13 14 and recent research.15–18

Overall, LEA rates have been on the decline in the USA with a slight increase more recently.19 It is unclear whether this trend has been consistent for patients of all races and for all regions, including the diabetes belt. Given that this area is home to some of the nation’s highest-risk patients, it is critical to understand how LEA rates have changed over time in this region.

Historically, Medicare has played a role in reducing racial disparities through many actions including desegregation of hospitals, data collection by race/ethnicity data to help identify disparities, and targeted programmes to reduce disparities.20 However, disparities persist. More recently, the Centers for Medicare and Medicaid Services (CMS) Office of Minority Health was formed with the mission to ‘lead the advancement and integration of health equity,’ including work to help rural Medicare patients have better access to high-quality care and reduce disparities for racial and ethnic minorities.21 In addition to Medicare efforts, the Affordable Care Act (ACA), a comprehensive federal statute in the USA that included many healthcare insurance and healthcare delivery reforms, supported the expansion of Federally Qualified Health Centers between 2011 and 2015.22 Medically underserved areas, including those in the diabetes belt, benefited from this increased access to care. However, patients who were cared for by these new health centres were less likely to be rural.23 It is unclear how minority health efforts have specifically affected rates of specific health conditions within the diabetes belt, where there is a combination of racial minority and rural populations.

Our objective is to examine how major LEA (MLEA) rates have changed in the diabetes belt and surrounding counties over the 10-year period surrounding the implementation of ACA (2006–2015) and whether and how it affected racial disparities in these regions. Further, we will explore factors that have a significant impact on MLEA rates that may be useful in identifying Medicare policies that could be implemented to further reduce MLEAs.

Methods

Data sources and study sample

We used a yearly sample of approximately 900 000 fee-for-service Medicare patients aged ≥65 years with diabetes over the years 2006–2015 to obtain MLEA rates per 1000 Medicare beneficiaries with diabetes. These annual samples were randomly selected from all beneficiaries with diabetes residing in the diabetes belt or surrounding areas. Racial/ethnic minorities and beneficiaries in sparsely populated counties were oversampled so that they can be adequately represented in the sample. The sampling procedures are discussed in detail elsewhere.24

Diabetes belt and surrounding areas

Following Barker et al,12 we identified 644 counties in the Appalachian region and southeastern part of the USA as the diabetes belt. This area consists mostly rural, mountainous and/or agricultural counties in the southern Appalachian region and an area popularly known as the Deep South in the USA. These are contiguous counties that had significantly higher rates of diabetes prevalence in 2008 compared with the rest of the country (11% or higher vs 8.5%).

For comparison, we identified two layers of counties that surround the diabetes belt. Due to concerns about confounding healthcare utilisation across county boundaries may create in our results, we decided not to include counties immediately adjacent to the diabetes belt as part of the surrounding counites. The surrounding areas then consist of 188 counties across 16 states.

Identification of diabetes

We obtained Medicare Beneficiary Summary Files for 2006–2015 for all beneficiaries and their matching chronic conditions segments for these years. Diabetes is one of the conditions that the CMS identified in that segment. In this study, we used the same CMS method of identification: a beneficiary is defined as having diabetes if one had one diagnosis code (ICD-9 or 10) or procedure code (CPT4/HCPCS) in Inpatient, Skilled Nursing Facility, or Home Health Agency records or 2 Outpatient or Carrier claims codes in each year or one was previously diagnosed with diabetes (eg, has a valid diagnosis date). The diagnostic and procedure codes used for patient identification are publicly available from the Chronic Conditions Data Warehouse.25

Major amputations and their risk factors

We identified MLEAs from Medicare inpatient, outpatient and carrier claims files in each year. We also identified their main risk factors including peripheral vascular disease, foot ulcers, peripheral neuropathy, Charcot arthropathy, osteomyelitis and gangrene for use in multivariable analyses. The diagnosis and procedure codes used to identify these conditions are shown in online supplemental table 1.

Covariates

Potential confounders for examining MLEA rates include patient demographics (age, sex, race/ethnicity, education and household income), Elixhauser comorbidities (excluding diagnosed diabetes and diabetes complications), diabetes treatment (oral medication alone, insulin alone and combination therapy), cholesterol treatment (statin treatment, other cholesterol treatment and combination therapy), state-level Medicaid buy-in status, urban/rural designation in three categories (rural, micropolitan and metropolitan) according to the US Department of Agriculture’s Rural-Urban Continuum Codes, Medicaid expansion status, Primary Care Incentive Payment (PCIP) qualifying doctor visit status and geographical access to primary care doctors based on the number of Medicare providers within a 15 min drive of the patient’s zip code centroid (low access: 0–5 providers, moderate access: 6–15 providers, good access: 16–50 providers and best access: 51 or more providers). For travel time, we obtained the list of all Medicare providers with addresses for their practice locations and computed travel time to the provider location obtained through address geocoding using a geographical information system software (ArcGIS Pro, ESRI, 2018). For race/ethnicity, we grouped patients into four categories, including non-Hispanic white, non-Hispanic black, Hispanic and other/unknown. White and black indicate non-Hispanic race designations hereafter.

County-level characteristics related to healthcare access were collected from the Area Health Resources File (Health Resources and Services Administration, 2018). Zip code-level data on socioeconomic status were collected from the American Community Survey 5-year data (US Census Bureau, 2015). We used the zip code-level percentage of adults completing high school and median household income as a proxy for patient education and household income. About 5% of patients could not be linked to the zip code-level data. For these patients, we used the county-level data were used to impute these values. Geospatial access was calculated using Medicare patient-level data and the National Plan and Provider Enumeration System data from the CMS.

Statistical analysis

To track the trends in major amputation rates for Medicare beneficiaries in the diabetes belt and surrounding areas, we computed the unweighted and weighted MLEA rates for the diabetes belt and the surrounding counties and for Black and White patients for each geographical area.

Using the data for 2015, we estimated a weighted logistic regression model to examine disparities in major amputation risks between the diabetes belt and surrounding areas, adjusting for diabetic foot complications, peripheral vascular disease, diabetes treatment and other factors that affect access to care and treatment of diabetes. Because persons with Hispanic ethnicity and those with other or unknown race/ethnicity accounted for less than 5% of the sample, we will focus on the comparisons between white and black patients in this study. For sensitivity analysis, we tested whether other access-to-care factors such as hospitals or healthcare professionals such as nurses and physician assistants in the same county can explain part of the disparities between regions and races/ethnicities.

For weighted rates, we used the survey commands in Stata SE V.15 (Stata). We applied appropriate subpopulation methods to obtain correct SEs for our estimates.

Patient and public involvement in the production of this paper was not appropriate or possible due to the nature of the study.

Results

The yearly sample size was between 898 428 and 899 846, representing a weighted population size ranging from 1 897 053 in 2006 to 2 214 129 in 2015. No patient in the samples was excluded on account of missing values such as race/ethnicity or zip code of residence. Table 1 presents the weighted population by year, the percentage of patients in the diabetes belt and surrounding counties, mean ages for each cohort, per cent female and race/ethnicity distributions.

Table 1
|
Weighted number of patients with diabetes in the DB and surrounding counties over 2006–2015 with the percentage of patients in the DB and surrounding counties, mean ages for each cohort, and sex and race/ethnicity distributions

MLEA rates were 3.9 per 1000 in the diabetes belt compared with 2.8 in the surrounding counties in 2006 and decreased to 2.3 and 1.6 per 1000 in 2015 (both p<0.001). The yearly weighted number of patients with foot ulcers and MLEAs by county type is shown in table 2 . Figure 1 presents (a) the yearly MLEA rates for patients in the diabetes belt compared with those in the surrounding counties and (b) the yearly MLEA rates by geographical area and race. Patients in the Belt experienced one full MLEA more per 1000 patients than those in the surrounding area. Black patients had 8.5 and 6.9 MLEAs per 1000 in 2006 and 4.8 and 3.5 in 2015 in the Belt and surrounding counties, respectively, while the rates were similar for white patients in the two areas (2.4 vs 2.1 in 2006 and 1.5 vs 1.3 in 2015).

Table 2
|
Weighted number and percentage of patients with foot ulcers and MLEAs by year and county type*
Figure 1
Figure 1

Major lower extremity amputation (LEA) rates by (A) geographical area and (B) geographical area and race in 2006–2015. All rates were weighted. NH, non-Hispanic.

Although amputation rates declined rapidly in both the Belt and the surrounding areas, black patients consistently had rates more than three times higher than white patients during the 10-year period in the Belt. Differences in rates between black and white patients were larger among patients in the diabetes belt than in the surrounding counties. The gap in rates between black and white patients narrowed over the study period. The trends did not show any noticeable changes in the MLEAs before and after the ACA.

Patients in the diabetes belt had a 44% higher rate of MLEA in 2015 compared with the surrounding areas. Table 3 presents the full model for a weighted logistic regression for MLEA controlling for covariates. We found that black patients had 22% higher odds (OR 1.216; 95% CI 1.057 to 1.400) of experiencing an MLEA compared with surrounding areas, adjusting for patient demographics, socioeconomic status, diabetic complications, comorbidities, antidiabetic and antilipemic medications, and access to care factors. When race/ethnicity was interacted with geographical regions, we found that blacks had 52% (OR 1.515; 95% CI 1.235 to 1.860) and 69% (OR 1.692; 95% CI 1.443 to 1.985) higher odds of having an MLEA compared with whites in the same region, while blacks in the diabetes belt had almost twice higher odds (OR 1.986; 95% CI 1.653 to 2.387) compared with whites in the surrounding areas (online supplemental table 2). In the same region, the odds of experiencing an MLEA were not significantly different between whites and Hispanic or other/unknown groups. Figure 2 displays the adjusted ORs for geographical region by race/ethnicity groups.

Table 3
|
Adjusted ORs and their 95% CIs of patients having a major amputation (N=899 401)*
Figure 2
Figure 2

Adjusted ORs for non-Hispanic whites and blacks in the diabetes belt and surrounding areas in 2015.The analysis was based on a model that included an interaction between geographical region (DM belt and surrounding areas) and race/ethnicity (NH white, NH black, Hispanic and other/unknown) in addition to all other factors in. p<0.001 for NH white-black comparisons within and across geographical regions. All other comparisons between NH white and other groups were not significant. The full model is shown in online supplemental table 3. DM, diabetes mellitus; NH, non-Hispanic.

Another model that included the number of short-term general hospitals, federally qualified health centres in county, and nurses and physician assistants in the county was estimated to examine how disparities in MLEA rates between geographical regions were after accounting for these additional factors for health services availability. The OR of patients in the diabetes belt having an MLEA was 1.188 (95% CI 1.031 to 1.369) compared with those in the surrounding areas after accounting for services availability. A cross-model test shows that the ORs for the diabetes belt compared with the surrounding areas beforeand after (online supplemental table 3) adjusting for services availability were not significantly different (ORs=1.216 vs 1.188; p=0.292). Other notable findings were that the odds of MLEA were higher for males, black patients (compared with white patients) and those with PCIP qualifying doctor visits, while they were lower for those with Medicaid buy-in and residents in states with expanded Medicaid (table 3). The number of short-term general hospitals and the physician assistants were significantly associated with reduced MLEA risk but the number of FQHC’s in the county was not (online supplemental table 3). The number of nurses in county who can provide healthcare services to patients with diabetes (advanced practice registered nurses, nurse practitioners, clinical nurse specialists, certified registered nurse anaesthetists and physician assistants) was associated with increased risk of MLEAs, while the number of physician assistants in the county was associated with decreased risk.

Discussion

Our data show persistent disparities in MLEA rates between the diabetes belt and surrounding areas. Over the 10-year study period, we consistently observed higher MLEA rates in the diabetes belt compared with the surrounding areas with rate ratios ranging from 1.37 to 1.56 over the study period (table 2). Both sets of counties exhibit large racial disparities in MLEA rates between white and black patients with larger disparities in the diabetes belt. Geographical differences may be attributed, in part, to a higher proportion of rural, black patients living in the diabetes belt than surrounding counties. This suggests racial minorities in the diabetes belt are doubly jeopardised for MLEA.

Our study was not designed to identify why black patients living the diabetes belt had higher rates of MLEA than their neighbouring counterparts. However, our findings linking rural residence, state Medicaid buy-in and limited care access to higher MLEA risks suggest an eroding healthcare infrastructure may be a factor.26 Over 80% of rural counties with majority Black populations are health professional shortage areas; most of these overlap with the diabetes belt.26 Furthermore, our group has shown that diabetes quality care metrics between the diabetes belt and surrounding counties are nearly equivalent after adjusting for provider shortages.27 When considering how efficient counties are in terms of providing diabetes preventive care, too few foot exams and eye exams were often identified as sources of inefficiencies.27 Although we did see a slowly narrowing gap in MLEA rates between regions and races over the horizon, there does not seem to be any clear evidence that this trend may have been affected by the ACA. A potential reason for this may be that expansion of federally qualified health centres had limited reach to rural patients, such as those that served in the diabetes belt.23

Our results are generally consistent with the declining trends in LEA rates in recent years that have amply been documented in the literature. Goldberg et al studied Medicare patients with diabetes over the period 1999–2006 and reported higher rates of amputation among Black patients.6 Margolis et al found a decreasing rate of incidence of LEA over 2006–2008 with higher rates clustered in some of the hospital referral regions in states overlapping with the diabetes belt, including Mississippi and Louisiana.28 29 Harding et al19 and Gregg et al30 presented amputation trends for patients 65 and older, with the general trend showing reduced rates of amputation during the early 2000s followed by flattening out or slight increase in amputation rates by around 2015. The findings of Harding et al19 are consistent with our work in that the rates for black patients are consistently higher than those for White patients. Our results go beyond what has previously been studied by providing rates for the diabetes belt specifically and highlighting the racial disparities in MLEA rates within the Belt and between the Belt and the surrounding counties.

Similar to the findings from Harding et al19 and Gregg et al,30 the rates among white patients in the diabetes belt and surrounding counties seem to be levelling off toward the end of the study period, potentially suggesting that we might have reached a floor for how low the MLEA rates can go under the current practice. Additional, targeted policies are needed to further reduce MLEA rates among disparity populations. Specifically, policies to prevent MLEAs among black patients in general and those in the diabetes belt are needed to eliminate the large racial disparities. Policies that specifically address patients in the diabetes belt should be prioritised given the disparity in MLEA rates between the diabetes belt and surrounding counties. These could include investing in healthcare infrastructure in rural counties with predominantly Black populations, which would potentially reduce both MLEA rates as well as disparities in premature death and other health outcomes.11 A policy specifically aimed at providing timely ambulatory care for Black patients, who are experiencing increasing difficulties accessing medical care independent of cost barriers,31 should be carefully considered.

Our results did not show any significant decreases in MLEAs after the ACA. While provisions of the ACA have reduced racial and rural disparities, further progress is needed.32 The CMS Office of Minority Health was one of six minority health offices established through the ACA to help highlight and address disparities. The geographical and racial MLEA disparities highlight a need for targeted interventions and strategies from the Office of Minority Health and other federal and local agencies to eliminate these disparities, particularly for the doubly disadvantaged black patients living in the diabetes belt.

As suggested by Eichner and Vladeck,20 Medicare can be a catalyst for reducing racial disparities in MLEA rates. CMS has several options to use for reducing disparities that include adjusting benefit and cost-sharing structures to reduce or eliminate out-of-pocket costs for low-income patients and implementing evidence-based guidelines for care to ensure all patients are treated with quality care despite physician bias. Further, CMS Quality Improvement Organisations can be used to engage patients at a community level to reduce disparities, an approach that would likely be helpful for reducing the regional and racial disparities we see in the diabetes belt.

Other research has highlighted potential approaches for reducing MLEA rates that may help reduce racial and geographical disparities. A pay-for-performance programme for diabetes providers that would provide incentives for reducing the rate of MLEAs may also have a significant impact on MLEA disparities.33 Multidisciplinary care teams including podiatrists, endocrinologists, wound care nurses and surgeons to manage diabetic foot ulcers have also become a recommended standard of care.34 These approaches are in line with Eichner and Vladeck’s suggestions for actions Medicare could take to address racial and ethnic health disparities, namely adjusting payment approaches and improving quality of care to reduce health disparities.

Limitations

Our work has limitations that need to be considered when interpreting our results. Some patient-level data were not available in the analysis, including behavioural factors such as smoking, physical activity, level of caregiving support for the patient and patient adherence to guideline recommendations such as daily foot checks, annual foot exams and A1c testing. These and other factors are relevant to the MLEA outcomes and may have confounded our results. We also were limited by the number of years of follow-up data we had available given that our most recent data are nearly a decade old. We plan to obtain additional years of follow-up to see whether these disparities continue to persist. The imputation of data at the zip code level using county-level data for the approximately 5% of patients who could not be linked to the zip code-level data is also a limitation.

Conclusion

Our findings show persistent disparities in the major amputation rates between the diabetes belt and surrounding counties, with racial disparities much larger in the Belt than in the surrounding areas. Targeted policies to prevent MLEAs among black patients are needed to reduce the persistent racial disparities, particularly for those black patients in the diabetes belt who are ‘doubly disadvantaged.’