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

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 1 drop of blood within 3 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, 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.

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 tele-medicine application for remote monitoring and treatment adjustments in terms of improving cardiovascular prevention.  This trial included a total of 3,439 patients evaluated between the March 1, 2019 and March 1, 2022, in the pre-pandemic period by face-to-face visits, and during the pandemic by tele-consultations or hybrid follow-up.  These researchers compared 4 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 Res-P, the percentage of obese, smoking, or hypertensive patients increased, but probably through the use of tele-medicine, these investigators managed to reduce it, although it remained slightly higher than the pre-pandemic level.  Physical activity decreased in the 1st year of the pandemic, but in Rel-P individuals became more active than before the pandemic.  The authors concluded that the use of tele-medicine for cardiovascular prevention appeared to yield favorable results, especially for secondary prevention in the very high-risk group and during the 2nd year.  Moreover, these researchers stated that he 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 tele-medicine.  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 tele-medicine.  That was why another difficulty was the fact that several older patients preferred to defer tele-medicine 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 tele-medicine technology in the elderly.  Fourth, this trial did not address the satisfaction level of patients or clinicians related to the dedicated tele-medicine 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 tele-medicine 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 in228 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.  Primary outcome was difference in systolic BP (SBP) and LDL-C between baseline and value after 3 months of follow-up.  Mean age in the intervention group was 62.7 years, 98 (88.3 %) patients were men.  A total of 26,449 mHealth measurements were recorded.  At 3 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.

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.  Th 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