Actigraphy Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM

EFFECTIVE DATE: 12|01|2014 POLICY LAST REVIEWED: 03|19|2025

OVERVIEW 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.

MEDICAL CRITERIA Not applicable

PRIOR AUTHORIZATION Not applicable

POLICY STATEMENT Medicare Advantage Plans Actigraphy is considered not covered when used as the sole technique to record and analyze body movement, including but not limited to its use to evaluate sleep disorders, as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Note: This does not include the use of actigraphy as a component of portable sleep monitoring. When used as a component of portable sleep monitoring, actigraphy should not be separately reported.

Commercial Products Actigraphy is considered not medically necessary when used as the sole technique to record and analyze body movement, including but not limited to its use to evaluate sleep disorders, as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Note: This does not include the use of actigraphy as a component of portable sleep monitoring. When used as a component of portable sleep monitoring, actigraphy should not be separately reported.

COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate section of the Benefit Booklet, Evidence of Coverage or Subscriber Agreement for applicable not medically necessary/not covered benefits/coverage.

BACKGROUND 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.

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 nondominant wrist with a wristband and are worn continuously for at least 24 hours. Activity is usually recorded for a period of 3 days to 2 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. Medical Coverage Policy | Actigraphy

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

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 (eg, 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 2 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.

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 measure levels of physical activity.

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 the effects of the technology on health outcomes.

For children and adolescents with sleep-associated disorders, in children and adolescents who receive actigraphy, the evidence includes prospective and retrospective validation studies. 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 the effects of the technology on health outcomes.

For individuals who have central disorders of hypersomnolence who receive actigraphy, the evidence includes a comparative observational study. 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 the effects of the technology on health outcomes.

For individuals who have insomnia who receive actigraphy, the evidence includes prospective and retrospective validation studies. Relevant outcomes are test accuracy and validity. Comparisons with PSG

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

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 the effects of the technology on health outcomes.

CODING Medicare Advantage Plans and Commercial Products The following code is not covered for Medicare Advantage Plans and not medically necessary for Commercial Products:
95803 Actigraphy testing, recording, analysis, interpretation and report (minimum of 72 hours to 14 consecutive days of recording)

RELATED POLICIES None

PUBLISHED Provider Update, May 2025 Provider Update, October 2024 Provider Update, August 2023 Provider Update, October 2022 Provider Update, April 2021

REFERENCES

1. Ford ES, Cunningham TJ, Giles WH, et al. Trends in insomnia and excessive daytime sleepiness among U.S. adults from2002 to 2012. Sleep Med. Mar 2015; 16(3): 372-8. PMID 25747141
2. Paquet J, Kawinska A, Carrier J. Wake detection capacity of actigraphy during sleep. Sleep. Oct 2007; 30(10): 1362-9.PMID 17969470
3. Meltzer LJ, Wong P, Biggs SN, et al. Validation of Actigraphy in Middle Childhood. Sleep. Jun 01 2016; 39(6): 1219-24.PMID 27091520
4. Enomoto M, Kitamura S, Nakazaki K. Validity of an algorithm for determining sleep/wake states using FS-760 in school-aged children. J Physiol Anthropol. Aug 18 2022; 41(1): 29. PMID 35982481
5. Yavuz-Kodat E, Reynaud E, Geoffray MM, et al. Validity of Actigraphy Compared to Polysomnography for Sleep Assessment in Children With Autism Spectrum Disorder. Front Psychiatry. 2019; 10: 551. PMID 31428003
6. O'Driscoll DM, Foster AM, Davey MJ, et al. Can actigraphy measure sleep fragmentation in children?. Arch Dis Child. Dec2010; 95(12): 1031-3. PMID 19850594
7. Hyde M, O'Driscoll DM, Binette S, et al. Validation of actigraphy for determining sleep and wake in children with sleep disordered breathing. J Sleep Res. Jun 2007; 16(2): 213-6. PMID 17542951
8. Bélanger MÈ, Bernier A, Paquet J, et al. Validating actigraphy as a measure of sleep for preschool children. J Clin SleepMed. Jul 15 2013; 9(7): 701-6. PMID 23853565
9. Insana SP, Gozal D, Montgomery-Downs HE. Invalidity of one actigraphy brand for identifying sleep and wake among infants. Sleep Med. Feb 2010; 11(2): 191-6. PMID 20083430
10. Spruyt K, Gozal D, Dayyat E, et al. Sleep assessments in healthy school-aged children using actigraphy: concordance with polysomnography. J Sleep Res. Mar 2011; 20(1 Pt 2): 223-32. PMID 20629939
11. Werner H, Molinari L, Guyer C, et al. Agreement rates between actigraphy, diary, and questionnaire for children's sleep patterns. Arch Pediatr Adolesc Med. Apr 2008; 162(4): 350-8. PMID 18391144
12. Short MA, Gradisar M, Lack LC, et al. The discrepancy between actigraphic and sleep diary measures of sleep in adolescents. Sleep Med. Apr 2012; 13(4): 378-84. PMID 22437142
13. Louter M, Arends JB, Bloem BR, et al. Actigraphy as a diagnostic aid for REM sleep behavior disorder in Parkinson's disease. BMC Neurol. Apr 06 2014; 14: 76. PMID 24708629

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 4 (401) 274-4848 WWW.BCBSRI.COM

14. Marino M, Li Y, Rueschman MN, et al. Measuring sleep: accuracy, sensitivity, and specificity of wrist actigraphy compared to polysomnography. Sleep. Nov 01 2013; 36(11): 1747-55. PMID 24179309
15. 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. Mar 15 2013; 9(3): 217-25. PMID 23493815
16. 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. Feb 01 2013; 9(2): 125-31. PMID 23372464
17. Kaplan KA, Talbot LS, Gruber J, et al. Evaluating sleep in bipolar disorder: comparison between actigraphy, polysomnography, and sleep diary. Bipolar Disord. Dec 2012; 14(8): 870-9. PMID 23167935
18. 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. Dec 2010; 31(12): 1623-33. PMID 21071830
19. Sivertsen B, Omvik S, Havik OE, et al. A comparison of actigraphy and polysomnography in older adults treated for chronic primary insomnia. Sleep. Oct 2006; 29(10): 1353-8. PMID 17068990

20. Smith MT, McCrae CS, Cheung J, 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. Jul 152018; 14(7): 1231-1237. PMID 2999143 i

    This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association. CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS