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Actigraphy refers to the assessment of activity patterns by devices placed on the wrist or ankle that record body movement, which is interpreted by computer algorithms as periods of sleep (absence of activity) and wake (activity). Sleep/wake cycles may be altered in sleep disorders including insomnia and circadian rhythm sleep disorders. In addition, actigraphy could potentially be used to assess sleep/wake disturbances associated with numerous other diseases or disorders. Actigraphy might also be used to measure the level of physical activity.
Actigraphic devices are typically 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 time periods with regular downloading of data onto a computer. The activity monitors may also be placed on the ankle for the assessment of restless legs syndrome, or on the trunk to record movement in infants.
The algorithms for detection of movement are variable among devices and may include “time above threshold,” the “zero crossing method” (the number of times per epoch that activity level crosses zero), or “digital integration” method, resulting in different sensitivities. Sensitivity settings (eg, low, medium, high, automatic) can also be adjusted during data analysis. The digital integration method reflects both acceleration and amplitude of movement; this form of data analysis may be most commonly used today.
Data on patient bed times (lights out) and rise times (lights on) are usually entered into the computer record 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 movement-related level of activity and periods of wake. In addition to providing graphic depiction of the activity pattern, device-specific software may analyze and report a variety of sleep parameters including sleep onset, sleep offset, sleep latency, total sleep duration, and wake after sleep onset. Actigraphy might 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. In addition, actigraphy is being investigated as a measure of sleep/wake disturbances associated with numerous other diseases and disorders.
Numerous actigraphy devices have received FDA clearance for marketing 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.
POLICYActigraphy is considered investigational when used as the sole technique to record and analyze body movement, including but not limited to its use to evaluate sleep disorders. This does not include the use of actigraphy as a component of portable sleep monitoring.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY7/21/2005: Approved by Medical Policy Advisory Committee (MPAC)
8/7/2006: Policy reviewed, no changes
9/18/2007: Policy reviewed, no changes
12/24/2008: Coding updated per the 2009 CPT/HCPCS revisions
8/14/2009: Policy reviewed, no changes
04/20/2011: Policy description updated; policy statement unchanged. Added FEP verbiage to the Policy Exceptions section. Removed deleted CPT code 0089T from the Code Reference section.
03/02/2012: Policy reviewed; no changes.
04/17/2013: Policy reviewed; no changes.
03/19/2014: Policy reviewed; no changes.
03/19/2015: Policy description revised. Investigational policy statement updated to state that actigraphy is considered investigational when used as the sole technique to record and analyze body movement, including but not limited to its use to evaluate sleep disorders. This does not include the use of actigraphy as a component of portable sleep monitoring.
07/02/2015: Code Reference section updated for ICD-10.
06/01/2016: Policy number A.2.01.73 added. Investigative definition updated in Policy Gudielines section.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.01.73
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.