Latest Review Date: June 2024

Category: Durable Medical Equipment (DME)             

POLICY:

Actigraphy to record and analyze body movement, including but not limited to its use to evaluate sleep disorders, is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Actigraphy refers to the assessment of body movement activity patterns using devices, typically placed on the wrist or ankle, during sleep, which are interpreted by computer algorithms as periods of sleep and wake. Sleep-wake cycles may be altered in sleep disorders, including insomnia and circadian rhythm sleep disorders. Also, actigraphy could be used to assess sleep/wake disturbances associated with other disorders.

Sleep Disorders

Sleep disorders affect a large percentage of the U.S. population. For example, estimates suggest that 15% to 24% of the U.S. population suffers from insomnia. Lack of sleep also contributes to reduced cognitive functioning, susceptibility to heart disease, and workplace absenteeism.

Diagnosis

Actigraphy refers to the assessment of activity patterns (body movement) using devices, typically placed on the wrist or ankle, which are interpreted by computer algorithms as periods of sleep (absence of activity) and wake (activity). Actigraphy devices are usually placed on the non-dominant wrist with a wristband and are worn continuously for at least 24 hours. Activity is usually recorded for a period of three days to two weeks but can be collected continuously over extended periods with regular downloading of data onto a computer. The activity monitors may also be placed on the ankle to assess restless legs syndrome or on the trunk to record movement in infants.

The algorithms for detecting movement vary across devices and may include "time above threshold," the "zero crossing method" (the number of times per epoch that activity level crosses zero), or the "digital integration" method, resulting in different sensitivities. Sensitivity settings (e.g., low, medium, high, automatic) can also be adjusted during data analysis. The most commonly used method (digital integration) reflects both acceleration and amplitude of movement.

Data on patient bedtimes (lights out) and rise times (lights on) are usually entered into the computer from daily patient sleep logs or by patient-activated event markers. Proprietary software is then used to calculate periods of sleep based on the absence of detectable movement, along with the movement-related level of activity and periods of wake. In addition to providing a graphic depiction of the activity pattern, the device-specific software can then analyze and report a variety of sleep parameters, including sleep onset, sleep offset, sleep latency, total sleep duration, and wake after sleep onset (actigraphy could also be used to measure the level of physical activity).

Actigraphy has been used for more than two decades as an outcome measure in sleep disorders research. For clinical applications, actigraphy is being evaluated as a measure of sleep-wake cycles in sleep disorders, including insomnia and circadian rhythm sleep disorders. Also, actigraphy is being investigated as a measure of sleep-wake disturbances associated with other diseases and disorders.

KEY POINTS:

This evidence review was created and updated regularly with searches of the PubMed database. The most recent literature update was performed through April 24, 2024.

Summary of Evidence:

For individuals who have circadian sleep-wake rhythm disorders who receive actigraphy, the evidence includes a comparative study that selected subjects from another main study evaluating the effects of caffeine on daytime recovery sleep. Relevant outcomes are test accuracy and test validity. Comparison with polysomnography (PSG) has shown that actigraphy is limited in differentiating between sleep and wake in more disturbed sleep. Actigraphy appears to reliably measure sleep onset and total sleep time in some patient populations. Comparisons with PSG and sleep diaries are limited. Evidence has shown that actigraphy does not provide a reliable measure of sleep efficiency in this patient population. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For children and adolescents with sleep-associated disorders who receive actigraphy, the evidence includes prospective and retrospective validation studies. The relevant outcomes are test accuracy and validity. Comparisons with PSG have shown that actigraphy can differ significantly in its estimations of wake and sleep times and sleep onset latency. Comparisons with sleep diaries have also failed to show satisfactory agreement, with greater discrepancies for more disturbed sleep. Evidence has shown that actigraphy does not provide a reliable measure of sleep efficiency in this patient population. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have central disorders of hypersomnolence who receive actigraphy, the evidence includes a comparative observational study. The relevant outcomes are test accuracy and validity. Comparison with video-PSG has indicated that actigraphy has a sensitivity of 26.1% and specificity of 95.5%. General evidence has also revealed that the accuracy of actigraphy for differentiating between wake and sleep decreases as the level of sleep disturbance increases. Although actigraphy appears to provide reliable measures of sleep onset and wake time in some patient populations, its clinical utility compared with that of sleep diaries has not been demonstrated. Evidence has shown that actigraphy does not provide a reliable measure of sleep efficiency in this patient population. The complexity of the various syndromes as well as the potential for medical treatment with significant adverse events makes accurate diagnosis essential. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have insomnia who receive actigraphy, the evidence includes prospective and retrospective validation studies. The relevant outcomes are test accuracy and validity. Comparisons with PSG have shown that actigraphy has a poor agreement for reporting wake time and can overestimate sleep efficiency. Comparison with sleep diaries has indicated that actigraphy is less effective at differentiating between patients with insomnia and controls. General evidence has also revealed that the accuracy of actigraphy for differentiating between wake and sleep decreases as the level of sleep disturbance increases. Although actigraphy appears to provide reliable measures of sleep onset and wake time in some patient populations, its clinical utility compared with sleep diaries has not been demonstrated. Evidence has shown that actigraphy does not provide a reliable measure of sleep efficiency in this patient population. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Academy of Sleep Medicine

The American Academy of Sleep Medicine (2018) published practice guidelines for the use of actigraphy for the evaluation of sleep disorders and circadian rhythm sleep-wake disorders (see Table 1).

Table 1. Recommendations for Actigraphy

Strong” recommendation is one that clinicians should follow under most circumstances.

“Conditional” recommendation reflects a lower degree of certainty regarding the outcome and appropriateness of the patient-care strategy for all patients.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Wrist actigraphic home monitoring, actigraphy, wrist-activity recording, wrist-activity monitoring, wrist mounted movement detector, ankle actigraphy monitoring, Actiwatch, SOMNOwatch

APPROVED BY GOVERNING BODIES:

Numerous actigraphy devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. Some actigraphy devices are designed and marketed to measure sleep-wake states while others are designed and marketed to measure levels of physical activity.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan. 

CURRENT CODING:

CPT Codes:

HCPCS:

REFERENCES:

1. Belanger ME, Bernier A, Paquet J et al. Validating actigraphy as a measure of sleep for preschool children. J Clin Sleep Med 2013; 9(7):701-6.
2. Blackwell T, Ancoli-Israel S, Redline S et al. Factors that may influence the classification of sleep-wake by wrist actigraphy: the MrOS Sleep Study. J Clin Sleep Med 2011; 7(4):357-67.
3. Dick R, Penzel T, Fietze I et al. AASM standards of practice compliant validation of actigraphic sleep analysis from SOMNOwatch™ versus polysomnographic sleep diagnostics shows high conformity also among subjects with sleep disordered breathing. Physiol Meas 2010; 31(12):1623-33.
4. Enomoto M, Kitamura S, Nakazaki K. Validity of an algorithm for determining sleep/wake states using FS-760 in school-aged children. JPhysiol Anthropol. Aug 18 2022; 41(1): 29.
5. Ford ES, Cunningham TJ, Giles WH, et al. Trends in insomnia and excessive daytime sleepiness among U.S. adults from 2002 to 2012. Sleep Med. Mar 2015; 16(3):372-378.
6. Insana SP, Gozal D, Montgomery-Downs HE. Invalidity of one actigraphy brand for identifying sleep and wake among infants. Sleep Med 2010; 11(2):191-6.
7. Kaplan KA, Talbot LS, Gruber J et al. Evaluating sleep in bipolar disorder: comparison between actigraphy, polysomnography, and sleep diary. Bipolar Disord 2012; 14(8):870-879.
8. Levenson JC, Troxel WM, Begley A et al. A quantitative approach to distinguishing older adults with insomnia from good sleeper controls. J Clin Sleep Med 2013; 9(2):125-31.
9. Louter M, Arends JB, Bloem BR, et al. Actigraphy as a diagnostic aid for REM sleep behavior disorder in Parkinson's disease. BMC Neurol. 2014; 14:76.
10. Marino M, Li Y, Rueschman MN et al. Measuring sleep: accuracy, sensitivity, and specificity of wrist actigraphy compared to polysomnography. Sleep 2013; 36(11):1747-55.
11. Meltzer LJ, Wong P, Biggs SN, et al. Validation of Actigraphy in Middle Childhood. Sleep. Jun 01 2016; 39(6):1219-1224.
12. O'Driscoll DM, Foster AM, Davey MJ et al. Can actigraphy measure sleep fragmentation in children? Arch Dis Child 2010; 95(12):1031-3.
13. Paquet J, Kawinska A and Carrier J. Wake detection capacity of actigraphy during sleep. Sleep 2007; 30(10): 1362-1369.
14. Plante DT. Leg actigraphy to quantify periodic limb movements of sleep: a systematic review and meta-analysis. Sleep Med Rev. Oct 2014; 18(5):425-434.
15. Sadaka Y, Sadeh A, Bradbury L, et al. Validation of actigraphy with continuous video-electroencephalography in children with epilepsy. Sleep Med. Sep 2014; 15(9):1075-1081.
16. Short MA, Gradisar M, Lack LC et al. The discrepancy between actigraphic and sleep diary measures of sleep in adolescents. Sleep Med 2012; 13(4):378-384.
17. Smith MM, McCrae CC, Cheung JJ, et al. Use of Actigraphy for the Evaluation of Sleep Disorders and Circadian Rhythm Sleep-Wake Disorders: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med, 2018 Jul 12;14(7). 
18. Spruyt K, Gozal D, Dayyat E et al. Sleep assessments in healthy school-aged children using actigraphy: concordance with polysomnography. J Sleep Res. 2011; 20(1 Pt 2):223-232.
19. Taibi DM, Landis CA, Vitiello MV. Concordance of polysomnographic and actigraphic measurement of sleep and wake in older women with insomnia. J Clin Sleep Med 2013; 9(3):217-25.
20. van der Kooi AW, Tulen JH, van Eijk MM et al. Sleep monitoring by actigraphy in short-stay ICU patients. Crit Care Nurs Q 2013; 36(2):169-73.
21. Yavuz-Kodat E, Reynaud E, Geoffray MM, et al. Validity of Actigraphy Compared to Polysomnography for Sleep Assessment in Children With Autism Spectrum Disorder.. 2019; 10: 551.

POLICY HISTORY:

Medical Policy Group, January 1993

Medical Policy Group, May 2004 (2)

Medical Policy Administration Committee, June 2004

Available for comment June 28-August 11, 2004

Medical Policy Group, June 2005 (4)

Medical Policy Group, May 2006 (1)

Medical Policy Group, May 2008 (1)

Medical Policy Group, May 2010 (1): Update to Description, Key Points, and References, no change in policy statement

Medical Policy Administration Committee; May 2010

Medical Policy Group, January 2012 (2): Updated Description, Key Points, References

Medical Policy Group, February 2012 (1): Update to Key Points and References related to MPP update; no change in policy statement

Medical Policy Panel, February 2013

Medical Policy Group, February 2013 (2): Update to Description, Key Points and References; no change in policy statement

Medical Policy Panel, February 2014

Medical Policy Group, February 2014 (3): Updates to Key Points & References; no change in policy statement

Medical Policy Panel, February 2015

Medical Policy Group, February 2015 (6): 2015 Updates to Key Points and References; no change to policy statement.

Medical Policy Panel, December 2016

Medical Policy Group, December 2016(6): Updates to Description, Summary, Practice Guidelines, Key Points, Key Words, Coding and References. No change to policy statement.

Medical Policy Panel, September 2017

Medical Policy Group, September 2017 (6): Updates to Description, Key Points and Practice Guidelines.

Medical Policy Panel, June 2018

Medical Policy Group, June 2018 (6): Updates to Key Points and References.

Medical Policy Panel, June 2019

Medical Policy Group, July 2019 (6): Updates to Key Points, Practice Guidelines and Position Statements, and References. No change to policy statement.

Medical Policy Group, September 2020 (6): Updated Coding to include E1399.

Medical Policy Panel, October 2020

Medical Policy Group, October 2020 (6): Updates to Key Points, Practice Guidelines and References.

Medical Policy Panel, June 2021

Medical Policy Group, June 2021 (6): Updates to Key Points.

Medical Policy Panel, June 2022

Medical Policy Group, June 2022 (6): Updates to Key Points and References.

Medical Policy Panel, June 2023

Medical Policy Group, June 2023 (6): Updates to Key Points, Benefit Application and References.

Medical Policy Panel, June 2024

Medical Policy Group, June 2024 (6): Updates to Key Points. Policy statement updated to remove “not medically necessary,” no change to policy intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.