Population Study: Lipid Treatment for Uninsured Populations with Severe Hypercholesterolemia

The characterization and treatment of severe hypercholesterolemia among patients within large health systems have been studied extensively.^1-6 However, little is known about the burden of disease at charity based or community clinics. These types of clinics often provide care for underserved, uninsured populations who are unable to access care even from safety-net healthcare systems.^7-9 An estimated 26 million uninsured patients rely on one of 1,400 charity/community clinics across the United States.¹⁰ Data have shown that uninsured populations are often at a disadvantage regarding management of hypercholesterolemia and other chronic diseases due to a limited access to preventive medicine and appropriate lifestyle change coaching, in addition to numerous health care barriers.^11,12

Barriers for Uninsured Populations

Despite data showing that nearly 40% of the medically underserved have previously undetected hypercholesterolemia, few efforts have been made to identify severe hypercholesterolemia amongst these individuals.¹³ Such individuals suffer from disparities in care, often receiving fewer treatments or non-guideline based therapies.¹⁰ There are several barriers affecting this population both involving the patients themselves, and the providers of care.

Patient focused barriers:

• Financial: The cost of medical care can be a major barrier in itself for uninsured individuals, who may not be able to afford the fees/co-pays associated with a visit to healthcare providers.¹⁴
• Limited access to care: Due to their uninsured status, these individuals may have limited access to care, particularly if they live in areas with shortages of healthcare providers.¹⁵
• Lack of knowledge about available resources: Uninsured individuals may be unaware of resources such as community clinics or government programs.¹⁵
• Stigma: Uninsured individuals may feel ashamed or embarrassed about their lack of insurance and may be hesitant to seek medical care as a result. Additionally, these individuals may fear that they will be turned away by healthcare providers due to their inability to pay for the cost of care.¹⁶ 

Clinic and provider focused barriers (system based) Limitations include:

• Resources: Free clinics may have limited funding, staff, and equipment, which can limit the types of services they can provide.^17,18
• Hours of operation: Many free clinics have limited hours of operation and may only be open a few days a week.
• Patient capacity: Free clinics may have limited capacity to see patients and may have long wait times or may not be able to see all patients who need care.¹⁷
• Services: Free clinics may not be able to provide all types of medical services, such as specialized care or certain types of medication.¹⁷
• Continuity of care: Patients may receive care at free clinics on a one-time basis, rather than receiving ongoing care from the same provider. Free clinics often have few dedicated providers, relying instead on volunteers. Such volunteers may have variable experience in managing chronic diseases.¹⁸

These challenges prevent uninsured individuals from receiving medical care they need and thus leads to delays in diagnosis and treatment of health conditions. Uninsured patients with hypercholesterolemia are more likely to be underdiagnosed and undertreated compared to those that are insured, leading to higher morbidity and mortality.^11,13,19,20

Our Experience at a Charity Community Clinic

To begin addressing the above issues, we sought to describe the burden of severe hypercholesterolemia at a primary care charity community clinic. North Dallas Shared Ministries (NDSM) is a charity community clinic providing care to uninsured populations not eligible to receive routine care from even safety-net healthcare systems.²¹ Services include treatment of minor illnesses, routine health visits, immunizations, dermatologic care, as well as screening and treatment of conditions such as hypertension and diabetes. The clinic also provides over-the-counter and prescription medications, lab work without cost to patients, and education and lifestyle counseling.²¹ 

Methods

We queried the electronic health record (EHR) at NDSM for all patients with at least one recorded LDL-C ≥ 190 mg/dL. Then, we called these patients to gather further past medical and family history related to Familial Hypercholesterolemia (FH), a genetic cause of severe hypercholesterolemia, and to ask them a series of questions about their knowledge of hypercholesterolemia.

Results

Between 2016 and 2020, LDL-C values were measured for 662 patients at the NDSM clinic. 27 patients had LDL-C ≥ 190 mg/dL (Table 1) with six having multiple LDL-C measurements ≥ 190 mg/dL. Over half (59%) did not have all the laboratory tests needed to exclude secondary causes of severe hypercholesterolemia (TSH, urine protein, and/or bilirubin). Almost all were prescribed statin medication (Table 1). After treatment, 14% of patients achieved LDL-C levels below 100 mg/dL and 10% had LDL-C levels that remained above 190 mg/dL. No patients had an ICD-10 diagnosis of FH or any mention of FH family screening within the medical record. 

We were able to contact and interview 13 of the patients with severe hypercholesterolemia (Table 2). Of the 13, only four patients reported currently adhering to statin therapy. They described several reasons for this treatment cessation, including intolerance, difficulty in obtaining prescription refills, and self-tapering of medication. Some patients reported self-tapering of their statin therapy due to feeling sick or unwell while on their medication. Others did so because they thought the higher dosage was not benefitting them more than a lower one. 

Discussion

We identified several gaps when leveraging the EHR to identify patients with LDL-C ≥ 190 mg/dL. Only 10% of all patients had lipid levels measured; few patients with severe hypercholesterolemia were on high-intensity statin drugs; and family history was missing in nearly all patients, as was laboratory work-up for secondary causes of severe hypercholesterolemia, making FH diagnosis based on criteria difficult. FH was not mentioned in any of their medical records. Subsequently, after calling the patients to gather more information, many had previously unknown family histories of premature ASCVD and hypercholesterolemia.

Our findings at NDSM are consistent – albeit more pronounced – with patient cohorts in various, large healthcare systems. Within our study, the population mean age of 52 and female predominance (67%) are similar to the demographics of previous studies of patients with severe hypercholesterolemia and possible FH.22-24 At NDSM, only 33% were prescribed a high-intensity statin compared to 42% of patients in the CASCADE-FH registry which was conducted across 11 different US lipid clinics.²² In addition, the treated LDL-C levels with statin therapy were higher in our study than in comparative studies both in the US and abroad.^22,24-26 

In our limited interviews, we were able to elicit issues affecting hypercholesterolemia treatment and medication adherence from the perspective of patients. These gaps in care and intolerance to medications are similar to barriers to FH care identified by Jones et al. in their interviews with patients diagnosed with Familial Hypercholesterolemia in a large healthcare system.²⁷ However, Jones et al. did not identify the inability to get prescriptions as a barrier to FH patient care.²⁷ We believe this may be due to the higher number of uninsured patients that are treated at NDSM relative to the 97% insured patient population that was interviewed by Jones et al. Although the reasons for provider under-prescribing and patient nonadherence are complex, these anecdotes give insight into specific opportunities at charity community clinics and may be an area of improvement.

Recommendations

Our findings suggest that there is not enough knowledge about FH and severe hypercholesterolemia in the patient population as well as among providers caring for them. Future efforts should address these issues, with patient education on hypercholesterolemia within charity community clinics as well as provider education about lipid screening and assessing patients with severe hypercholesterolemia. This work must take into account social determinants of health for this population since they likely lead to inequities in care. Income is likely the most obvious social determinant of health in the uninsured. While statins are generic and inexpensive, patients with severe hypercholesterolemia often require multiple lipid lowering drugs, increasing the overall cost of treatment. Providers should keep in mind that PCSK9 monoclonal antibodies and siRNA drugs may be obtainable via patient assistance programs from the manufacturer. Another social determinant of health is health education. As noted by the results of our interviews, efforts are warranted to improve cholesterol education in the uninsured population. A third social determinant of health is social/societal support with regards to navigating the healthcare system. Uninsured individuals may have difficulty with finding free clinics such as NDSM and then setting up and attending regular clinic visits needed to monitor chronic conditions such as hypercholesterolemia. Addressing these social determinants of health will be crucial in helping uninsured people with severe hypercholesterolemia to effectively manage the condition and lower their risk of developing cardiovascular disease. 

When caring for these patients, providers need to be aware of the barriers that uniquely affect their care. Understanding this will help to address the factors impacting the proper treatment of chronic diseases within this population such as severe hypercholesterolemia. 

Mr. Peedikayil has no financial relationships to disclose. Dr. Ahmad has no financial relationships to disclose.

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