Benefit Application
Plans may wish to review their contract language to ensure that the contract language is consistent with the Plan’s medical policy. 

Description
PURPOSE 
To provide parameters for medical necessity determination when Durable Medical Equipment (DME) benefits are requested for a light box for the treatment of Seasonal Affective Disorder (SAD) and to ensure benefit coverage is applied in a consistent manner. This document is not a standard of care, but is developed utilizing industry standard guidelines, peer reviewed literature and current evidence-based recommendations.

DESCRIPTION 
Light therapy for certain affective disorders has been researched for over 30 years.  A meta-analysis by Golden, et al., provides a comprehensive review of all of these studies. The light units typically deliver 10,000 lux, using cool white, fluorescent bulbs.

The SAD diagnosis is not a Diagnostic and Statistical Manual of Mental Disorders (DSM) category. Rather, it is a specifier. Essentially, the description for this as a specifier includes:

1. Onset/remission at characteristic times of the year, typically with a fall/winter onset, and remission during the summer months. Onset may occur rarely in the summer, with remission during the winter.
2. In the last two years, two major depressive episodes have occurred and have a seasonal relationship with no non-seasonal major depressive episodes in the same time period.
3. Over the lifetime course of the illness, seasonal episodes must substantially outnumber non-seasonal events.
4. Younger age groups are at higher risk, as are women.
5. Prevalence increases with higher latitudes.
6. Symptoms are generally consistent with an atypical affective syndrome: very low energy, hypersomnia, overeating with weight gain and carbohydrate craving.
7. The seasonal specifier may be used with the following DSM diagnoses:
   1. Major Depressive Disorder, recurrent.
   2. Bipolar Disorder I: manic, hypomanic, mixed, depressed or unspecified.
   3. Bipolar Disorder II: hypomanic or depressed.

TREATMENT
The amount of light delivered in each treatment is typically 5000-lux hours. This could be delivered by 10,000-lux units in 30 minutes of exposure, 5000-lux units for one hour or 2500-lux units for 2 hours, etc. Each light unit will document a specific distance for the individual from the unit, so that a user will be able to determine placement for maximum benefit (approximately 12-24 inches, eyes open, but not directly looking at the light). The manufactured units should all have UV shielding. Initially, the individual should limit exposure to 10 minutes for 10,000 lux, but quickly escalate to the desired dose of 5000-lux hours. The exposure time is also usually in the morning, upon awakening.

Response may be within days, and usually by the end of the first week, many patients report significant improvement.  However, a full trial would be four weeks in length. Mild adverse treatment reactions include: headaches (13 to 21%), nausea (7%), sweating (7%), sedation (7%), dizziness and eyestrain/visual disturbances (19-27%). There are no known effects of short-term use on vision, but long-term use has not been studied. More serious adverse treatment reactions that should be reported to the attending physician and may require regime modification include irritability, feeling “wired” (6-13%), progressing on to hypomania and rarely to mania. Overall, the rate of response is thought to be 65%.

It is generally recommended that exposure to the light box be continued through the typical time of the seasonal illness. During some studies, missing two to three days of treatment was not associated with relapse, but longer periods without light exposure did result in symptomatic worsening/return.

Individuals with pre-existing ophthalmic problems may benefit from consultation. These disorders would include retinal detachment, retinitis pigmentosa, glaucoma, macular degeneration, diabetes mellitus, previous cataract surgery, and lens removal. Medications that may cause increased photosensitivity should also be scrutinized.  These include lithium, phenothiazines, chloroquine, hematoporphyrins, 8-methoxypsoralens, melatonin and hypericum (St. John’s Wort). 

Policy 
MEDICAL NECESSITY GUIDELINES

1. Light therapy (phototherapy) may be considered medically necessary for the treatment of seasonal and non-seasonal affective disorders, but not for mania or hypomania.
2. Patient should be between 18 to 65 years of age.
3. Diagnoses covered:
   1. Major Depressive Episode, Single (F32.x) Recurrent (F33.x).
   2. Bipolar I Disorder, depressed (F31.3X or F31.4), unspecified (F31.9).
   3. Bipolar II Disorder (F31.81).
4. The request for the DME must be generated by a physician with specialized training in psychiatry and the policy must have a DME benefit.
5. Only desktop units of 10,000 lux with UV shielding will be covered.  Visors, dawn simulation units, dual use tanning lights and popliteal units are not covered.  
6. Pertinent codes are:
   1. 6A600ZZ: Phototherapy of Skin, single.
   2. E0203 (HCPCS): therapeutic light box, minimum 10,000 lux, tabletop.
   3. A4634: Bulb replacement for E0203.
   4. 96900 (CPT): actinotherapy (ultraviolet light)

References

1. American Psychiatric Association. (2013). Diagnostic and Statistical Manual of Mental Disorders (5th ed.).  Washington, DC:  
2. Blue Cross and Blue Shield Associate Technology Evaluation Center.  (2006, March).  Phototherapy Light for the Treatment of Seasonal Affective and Other Depressive Disorders.  Document 1.01.04.
3. Brouwer A, van Raalte DH, Diamant M, et al. Light therapy for better mood and insulin sensitivity in patients with major depression and type 2 diabetes: A randomized, double-blind, parallel-arm trial. BMC Psychiatry. 2015;15:169.
4. Caldieraro MA, Cassano P. Transcranial and systemic photobiomodulation for major depressive disorder: A systematic review of efficacy, tolerability and biological mechanisms. J Affect Disord. 2019;243:262-273.
5. Campbell PD, Miller AM, Woesner ME. Bright Light Therapy: Seasonal Affective Disorder and Beyond. Einstein J Biol Med. 2017;32:E13-E25. 
6. Cassano P, Petrie SR, Mischoulon D, et al. Transcranial photobiomodulation for the treatment of major depressive disorder. The ELATED-2 pilot trial. Photomed Laser Surg. 2018;36(12):634-646.
7. Danilenko KV, Ivanova IA. Dawn simulation vs. bright light in seasonal affective disorder: Treatment effects and subjective preference. J Affect Disord. 2015;180:87-89.
8. Golden RN, Gaynes BN, Ekstrom RD, Hamer RM, Jacobsen FM, Suppes T, Wisner KL, & Nemeroff CB. (2005).  The Efficacy of Light Therapy in the Treatment of Mood Disorders: A Review and Meta-Analysis of the Evidence. The American Journal of Psychiatry. 162:656-662.
9. Lam RW and Levitt AJ. Canadian Consensus Guidelines for the Treatment of SAD.  A Summary of the Report of the Canadian Consensus Group on SAD.  Available online at: http://www.instantdaylite.com/downloads/canadian_sad_light_therapy.pdf.   Last accessed September 13, 2013.
10. Martensson B, Pettersson A, Berglund L, & Ekselius L (2015). Bright white light therapy in depression: A critical review of the evidence. J Affect Disord. 182:1–7.
11. Postolache T, and Oren DA. (2005). Circadian Phase Shifting, Alerting and Antidepressant Effects of Bright Light Treatment.  Clinics in Sport Medicine. 24:381-413.
12. Saeed SA and Bruce TJ. (1998). Seasonal Affective Disorders.  American Family Physician. 57:1340-1357.
13. Sit DK, McGowan J, Wiltrout C, et al. Adjunctive bright light therapy for bipolar depression: A randomized double-blind placebo-controlled trial. Am J Psychiatry. 2018;175(2):131-139.
14. Takeshima M, Utsumi T, Aoki Y, et al. Efficacy and safety of bright light therapy for manic and depressive symptoms in patients with bipolar disorder: A systematic review and meta-analysis. Psychiatry Clin Neurosci. 2020;74(4):247-256.
15. Wang S, Zhang Z, Yao L, et al. Bright light therapy in the treatment of patients with bipolar disorder: A systematic review and meta-analysis. PLoS One. 2020;15(5):e0232798.
16. Zhao X, Ma J, Wu S, et al. Light therapy for older patients with non-seasonal depression: A systematic review and meta-analysis. J Affect Disord. 2018;232:291-299.
17. Zhou TH, Dang WM, Ma YT, et al. Clinical efficacy, onset time and safety of bright light therapy in acute bipolar depression as an adjunctive therapy: A randomized controlled trial. J Affect Disord. 2018;227:90-96.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community,  and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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