Home Cholesterol Monitors

Number: 0367

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

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Policy

Scope of Policy

This Clinical Policy Bulletin addresses home cholesterol monitors.

1. Experimental, Investigational, or Unproven

   Aetna considers cholesterol monitors for home use (e.g., Cholestron cholesterol monitor, and molecularly imprinted membrane modified gel colorimetric device) experimental, investigational, or unproven because effective treatment of elevated cholesterol levels does not require daily blood testing. Thus, the value of home monitoring over periodic laboratory testing has not been established.

2. Related Policies

   • CPB 0525 - Screening for Lipid Disorders

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Table:

CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
HCPCS codes not covered for indications listed in the CPB:
Home cholesterol monitors, Molecularly imprinted membrane modified gel colorimetric device-no specific code:
A9279	Monitoring feature/device, stand-alone or integrated, any type, includes all accessories, components and electronics, not otherwise classified [not covered for home cholesterol monitors]
ICD-10 codes not covered for indications listed in the CPB (not all-inclusive):
E71.30, E75.21 - E75.22, E75.240 - E75.249, E75.3, E75.6, E77.0 - E77.9, E78.00 - E78.9, E88.1 - E88.2, E88.89	Disorders of lipoid metabolism
Z13.220	Encounter for screening for lipoid disorders

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Background

Home cholesterol monitors are consumer-directed point‑of‑care devices intended to measure total cholesterol and, in some cases, selected lipid fractions outside of a clinical laboratory setting. While certain FDA‑cleared devices demonstrate analytic accuracy comparable to laboratory methods under controlled conditions, their clinical utility in routine cholesterol management remains unproven. Contemporary evidence‑based guidelines from the American College of Cardiology (ACC) and American Heart Association (AHA) emphasize that lipid management is guided by overall atherosclerotic cardiovascular disease risk and response to therapy, with lipid testing recommended at periodic intervals to assess baseline risk, treatment adherence, and therapeutic response—not through frequent or daily monitoring. Lipid levels change gradually, and effective treatment decisions for dyslipidemia are based on long‑term trends rather than short‑term fluctuations.

Cholestron (Lifestream Technologies, Post Falls, ID) is a hand-held device that measures cholesterol. It is about the size of a palmtop computer and can screen a patient's overall cholesterol level with one drop of blood within three minutes. It was cleared by the U.S. Food and Drug Administration on October 5, 1998, and is manufactured by Lifestream Technologies Inc. Recommended conservative treatments for hypertension and hyperlipidemia include changes in dietary habits, an increase in physical activity, and, if necessary, drug therapy. There are no prospective studies demonstrating that home monitoring of cholesterol improves clinical outcomes compared to periodic testing performed in the clinic.

Kurstjens et al. (2021) highlight that hypercholesterolemia, defined as a plasma cholesterol concentration of ≥5.2 mmol/L, is a significant risk factor for cardiovascular disease and stroke. Despite the availability of various cholesterol self-tests in general stores, pharmacies, and online shops, there is limited information regarding their analytical and diagnostic performance. In their study, the authors included 62 adult patients who required lipid panel measurements (cholesterol, high-density lipoprotein [HDL], triglycerides, and LDL calculated) for routine care. They assessed the performance of 5 different cholesterol self-tests, which included 3 quantitative meters (Roche Accutrend Plus, Mission 3-in-1, and Qucare) and 2 semi-quantitative strip tests (Veroval and Mylan MyTest), following the manufacturers' protocols. The average plasma cholesterol concentration among participants was 5.2 ± 1.2 mmol/L. The mean absolute relative difference (MARD) for the 5 self-tests ranged from 6 ± 5% for the Accutrend Plus to 20 ± 12% for the Mylan MyTest. The Accutrend Plus demonstrated the best diagnostic performance, achieving 92% sensitivity and 89% specificity. Additionally, the Qucare and Mission 3-in-1 meters were capable of measuring HDL concentrations, allowing for the calculation of a cholesterol:HDL ratio; however, the Passing-Bablok regression analyses indicated poor performance for both self-tests (Mission 3-in-1: y = 1.62x - 1.20; Qucare: y = 0.61x + 1.75). Notably, the Accutrend Plus was unable to measure plasma HDL concentration. The authors concluded that while the Accutrend Plus cholesterol meter exhibited excellent diagnostic and analytical performance, many commercially available self-tests demonstrated significantly poor accuracy and diagnostic performance, failing to meet necessary qualifications and potentially leading to erroneous results. The authors advocate for improved regulation, standardization, and harmonization of cholesterol self-tests.

Iliuța et al. (2023) noted that cardiovascular prevention was left in second place during the COVID-19 pandemic, and the use of telemedicine turned out to be very useful. In a prospective, single-center study, these investigators examined the effectiveness of a telemedicine application for remote monitoring and treatment adjustments in terms of improving cardiovascular prevention. This trial included a total of 3,439 patients evaluated between March 1, 2019, and March 1, 2022, in the pre-pandemic period by face-to-face visits, and during the pandemic by teleconsultations or hybrid follow-up. These researchers compared four periods: pre-pandemic (Pre-P; March 1, 2019, to March 1, 2020), lockdown (Lock; March 1 to September 1, 2020), restrictive-pandemic (Restr-P; September 1, 2020, to March 1, 2021), and relaxed-pandemic (Rel-P; March 1, 2021, to March 1, 2022). The average values of total cholesterol (TC), LDL cholesterol, triglycerides, uric acid, and glucose had an increasing trend during Lock and Restr-P, and they decreased close to the baseline level during the Rel-P, with the exception of glucose, which remained elevated in Rel-P. The number of patients with newly discovered diabetes mellitus (DM) increased significantly in the Rel-P, and 79.5% of them had mild/moderate forms of COVID-19. During Lock and Restr-P, the percentage of obese, smoking, or hypertensive patients increased, but probably through the use of telemedicine, these investigators managed to reduce it, although it remained slightly higher than the pre-pandemic level. Physical activity decreased in the first year of the pandemic, but in Rel-P individuals became more active than before the pandemic. The authors concluded that the use of telemedicine for cardiovascular prevention appeared to yield favorable results, especially for secondary prevention in the very high-risk group and during the second year. Moreover, these researchers stated that the findings of this trial were based on the information obtained at a certain moment of the health crisis and did not represent the general experience in the practice of cardiovascular prevention. They stated that further investigations could examine the perspectives regarding cardiovascular online prevention and the implications of its use on a large scale and for a more sustained period and in a non-pandemic context. These investigators stated that their experience highlighted the benefits of this remote prevention strategy in various risk groups of patients and encouraged larger studies to confirm these findings.

The authors stated that this study had several drawbacks. First, it was a single-center study and had a short period of follow-up during the pandemic compared with the pre-pandemic period and a low event number. However, these researchers examined a large number of parameters. Unlike other monitoring strategies that rely on direct-to-consumer technologies (e.g., smartphones), which are more likely to appeal to younger patient populations, the system used in this study was provided and supported by the authors’ clinic. The authors could not exclude that some patients already applied for some form of self-quarantine. Because the present findings were obtained with a multi-parametric approach in a structured remote monitoring center, they represented a complex intervention, and their generalizability to different technologies or other organizations is unknown. Second, this trial also highlighted some of the limitations of using telemedicine. During an in-person patient encounter, obtaining a patient blood sample was very easy; however, 14% of patients failed to go to the testing laboratory. Third, these investigators were unable to carry out physical examinations via telemedicine. That was why another difficulty was the fact that several older patients preferred to defer telemedicine visits in favor of obtaining in-person visits, despite their higher risk for COVID-19 exposure. This may have been due to a lower comfort level with telemedicine technology in the elderly. Fourth, this trial did not address the satisfaction level of patients or clinicians related to the dedicated telemedicine application, which is an important aspect that should be addressed in future qualitative studies. Fifth, these researchers did not have information regarding specific technical difficulties during telemedicine visits.

Biersteker et al. (2023) stated that lowering low-density lipoprotein (LDL-C) and blood pressure (BP) levels to guideline-recommended values reduces the risk of major adverse cardiac events in patients who underwent coronary artery bypass grafting (CABG). To improve cardiovascular risk management, this study examined the effects of mobile health (mHealth) on BP and cholesterol levels in patients following stand-alone CABG. This study was a post-hoc analysis of an observational cohort study in 228 adult patients who underwent stand-alone CABG surgery at a tertiary care hospital in the Netherlands. A total of 117 patients received standard care, and 111 patients underwent an mHealth intervention. This consisted of frequent BP and weight monitoring with regimen adjustment in case of high BP. The primary outcome was the difference in systolic BP (SBP) and LDL-C between baseline and value after three months of follow-up. Mean age in the intervention group was 62.7 years, and 98 (88.3%) patients were men. A total of 26,449 mHealth measurements were recorded. At three months, SBP decreased by 7.0 mmHg (standard deviation [SD]: 15.1) in the intervention group versus -0.3 mmHg (SD: 17.6; p < 0.00001) in controls; body weight decreased by 1.76 kg (SD: 3.23) in the intervention group versus -0.31 kg (SD: 2.55; p = 0.002) in controls. Serum LDL-C was significantly lower in the intervention group versus controls (median: 1.8 versus 2.0 mmol/L; p = 0.0002). The authors concluded that the findings of this study showed an association between home monitoring following CABG and a reduction in SBP, body weight, and serum LDL-C; however, the causality of the association between the observed weight loss and decreased LDL-C in intervention group patients remained to be investigated. Moreover, these researchers stated that long-term effects of mHealth on lifestyle and cardiovascular risk management could not yet be assessed and need to be addressed in further research.

The authors stated that the non-randomized nature and inclusion of a historical control group were a major drawback of this trial. Furthermore, selection bias may have occurred due to the impact of COVID-19 after March 2020. This was the main reason for some differences at baseline, such as age, history of hypertension, and length of stay. These investigators corrected for these parameters in the statistical analyses.

Mutepfa et al. (2025) state that there is a need to better inform clinicians and decision-makers in primary or community care settings about selecting appropriate point-of-care tests (POCTs) for screening as part of the NHS Health Check Programme. This study provides an overview of the published analytic validity and diagnostic accuracy studies on POCTs for measuring blood lipids available on the UK market to determine whether they meet the accuracy specifications based on the 1995 US National Cholesterol Education Program (NCEP) recommendations. The design involved a rapid review of analytical validity and diagnostic accuracy studies. Data sources included searches of Medline and Embase conducted on May 12, 2023, along with a manual review of Google Scholar and key article reference lists to identify additional studies. The eligibility criteria focused on analytical validity and diagnostic accuracy studies that compared POCT performance to laboratory testing (or another POCT) for measuring at least total cholesterol (TC) and high-density lipoprotein cholesterol (HDL-C). Data extraction and synthesis involved independent review of identified studies by two researchers using standardized screening methods, with conflicts resolved by a third reviewer when necessary. Title and abstract screening, as well as full-text reviews, were conducted using pre-specified inclusion and exclusion criteria. The quality of identified studies was assessed using QUADAS-2 for diagnostic accuracy studies and a modified quality appraisal tool for studies of diagnostic reliability (QAREL) for analytical validity studies. The study assessed the quality of analytical and diagnostic accuracy studies and compared the accuracy of the POCTs for TC, triglycerides (TG), HDL-C, and low-density lipoprotein cholesterol (LDL-C) against NCEP standards for mean percent bias, coefficient of variation, or total error. The results indicated that this study examined analytical and diagnostic accuracy evidence for the selected POCTs, reviewing 22 studies and identifying six POCTs. All retrieved studies were analytical validity assessments, while five also reported diagnostic accuracy information. The majority of evidence focused on Cholestech LDX, CardioChek PA, and Accutrend Plus, with evidence of between- and within-study heterogeneity found. Precision measures often showed systematic differences between the POCTs and reference standards, and most devices, except for Elemark, met at least one NCEP standard for TC, TG, HDL-C, or LDL-C. The strengths and limitations of this study include addressing concerns raised by primary care staff about the reliability of POCT results compared with laboratory testing in the NHS Health Check Programme. This rapid review narratively synthesizes analytical and clinical validity evidence of POCTs measuring cholesterol, providing reassurance about the performance and safety of two POCTs with similar performance characteristics to laboratory testing that could be used in clinical practice. This review serves as a guide for healthcare professionals, managers, and researchers in their decision-making when selecting appropriate POCTs that best fit the multifaceted requirements of their settings. Although evidence such as clinical utility and health economics was not considered, it may play a role in policymaking. In conclusion, the study found that evidence for two of the devices mostly met the requirements of the NCEP standard for bias and precision and could be recommended to general practitioners for use in the NHS Health Check Programme; these devices were the Cholestech LDX and the Cobas b101 system.

The updated 2026 clinical practice guideline from the American College of Cardiology and the American Heart Association Joint Committee on the management of dyslipidemia does not include recommendations for at-home cholesterol testing as a substitute for laboratory-based testing.

Molecularly Imprinted Membrane Modified Gel Colorimetric Device

Zhang et al. (2022) noted that simple and disposable monitoring of blood is usually the best solution for early clinical diagnosis and home self-inspection of the chronic patients. These researchers described for the very first time a simple point-of-care (POC) device that utilizes molecularly imprinted membrane modified gel colorimetric device (MIMGCD) for whole blood cholesterol colorimetric detection. The principle of this device relies on molecularly imprinted membranes for specifically separating cholesterol from whole blood firstly, followed by the use of the gold bipyramids (GBPs) agarose gel system, which reacts with the cholesterol oxidation to product hydrogen peroxide (H2O2), and the cholesterol will then be quantified based on the color change. Under optimal conditions, the analytical performance of the proposed device yielded a linear range of 315.8 to 6,000.0 μM and detection limit of 94.7 μM with 6.89% relative standard deviation (RSD) for cholesterol, which could meet the needs of the detection of normal cholesterol content in the human body. Compared with the traditional whole blood detection methods, no complex sample preparation steps or precision instruments are needed, endowing MIMGCD with the merits of easy to operate and low-cost. Furthermore, the multi-color variation of GBPs in the device allows a colorimetric card-like detection mechanism, which could be used for home self-inspection. The authors concluded that this device has the potential to be used in clinical and home POC testing application for whole blood biomolecule analysis; thus, facilitating the whole blood screening and long-term monitoring in non-specialized laboratory infra-structure.

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References