Latest Review Date: July 2024                                                                     

Category: Durable Medical Equipment (DME)

POLICY:

The use of digital health therapies for therapeutic applications is considered investigational for all indications, including but not limited to:

• Depression
• Nightmare disorders
• Panic disorder
• PTSD
• Urinary Incontinence

DESCRIPTION OF PROCEDURE OR SERVICE:

Digital health technologies is a broad term that includes categories such as mobile health, health information technology, wearable devices, telehealth and telemedicine, and personalized medicine. These technologies span a wide range of uses, from applications in general wellness to applications as a medical device, and include technologies intended for use as a medical product, in a medical product, as companion diagnostics, or as an adjunct to other medical products (devices, drugs, and biologics). The scope of this review includes only those digital technologies that are intended to be used for therapeutic application and meet the following 3 criteria: 1) Must meet the definition of "Software as a medical device" which states that software is intended to be used for a medical purpose, without being part of a hardware medical device or software that stores or transmits medical information. 2) Must have received marketing clearance or approval by the U.S. Food and Drug Administration (FDA) either through the de novo pre-market process or 510(k) process or pre-market approval and 3) Must be prescribed by a healthcare provider.

Scope of Review

Software has become an important part of product development and is integrated widely into digital platforms that serve both medical and non-medical purposes. The 3 broad categories of software use in medical devices are:

1. Software used in the manufacture or maintenance of a medical device (e.g., software that monitors x-ray tube performance to anticipate the need for replacement),
2. Software that is integral to a medical device or software in a medical device (e.g., software used to "drive or control" the motors and the pumping of medication in an infusion pump),
3. Software, which on its own is a medical device referred to as "Software as a Medical Device" (SaMD) (e.g., software that can track the size of a mole over time and determine the risk of melanoma).

The International Medical Device Regulators Forum, a consortium of medical device regulators from around the world led by the U.S. Food and Drug Administration (FDA) defines SaMD as "software that is intended to be used for one or more medical purposes that perform those purposes without being part of a hardware medical device”. Such software was previously referred to by industry, international regulators, and health care providers as "standalone software," "medical device software," and/or "health software," and can sometimes be confused with other types of software.

The scope of this review includes only those digital technologies that are intended to be used for therapeutic application and meet the following 3 criteria:

1. Must meet the definition of "Software as a medical device" (SaMD) which states that software is intended to be used for a medical purpose, without being part of a hardware medical device or software that stores or transmits medical information.
2. Must have received marketing clearance or approval by the U.S. FDA either through the de novo pre-market process or 510(k) process or pre-market approval and,
3. Must be prescribed by a healthcare provider.

BCBSA Evaluation Framework for Digital Health Technologies

SaMDs, as defined by the FDA, are subject to the same evaluation standards as other devices; the Blue Cross and Blue Shield Association Technology Evaluation Criterion are as follows:

1. The technology must have final approval from the appropriate governmental 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._a
4. The technology must be as beneficial as any established alternatives.
5. The improvement must be attainable outside the investigational settings._b

_a The technology must assure protection of sensitive patient health information as per the requirements of The Health Insurance Portability and Accountability Act of 1996 (HIPAA).

_b The technology must demonstrate usability in a real-world setting.

Other regulatory authorities such as the United Kingdom's National Institute for Health and Care Excellence (NICE) have proposed standards to evaluate SaMD.

KEY POINTS:

The most recent literature update was performed through March 12, 2024.

Summary of Evidence

For individuals with panic symptoms who receive Freespira, the evidence includes several single-arm studies. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Panic symptoms in individuals with panic disorder and post-traumatic stress disorder (PTSD) have been associated with more shallow and rapid breathing, and Freespira is intended to lead to more regular breathing through biofeedback over a 4-week training period. There are 2 single-arm studies in individuals with panic disorder and 1 single-arm pilot study on the use of Freespira in individuals with PTSD. All of the studies report an improvement in symptoms but are limited by loss to follow-up that ranges from 24% to 58% and multiple limitations in the design and conduct. A well-designed blinded randomized controlled study with a clear design for testing a pre- specified hypothesis is needed. Given the high loss to follow-up and lack of a control group in these studies, the benefit of a 4-week program of respiratory biofeedback in individuals with panic disorder and PTSD is uncertain. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with nightmare disorder or PTSD-associated nightmares who receive NightWare, the evidence includes a single trial. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The single pivotal trial did not meet the primary efficacy endpoint. This trial failed to achieve recruitment goals and was likely underpowered. A well-designed blinded randomized controlled study with a clear design for testing a pre-specified hypothesis is needed. Given these limitations, the benefit of NightWare in individuals with nightmare disorder and post-traumatic stress disorder-associated nightmares is uncertain. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with depression who receive Deprexis®, the evidence includes RCTs and a meta-analysis. Studies reviewed lacked long-term follow-up and some lacked outcome ratings beyond self-reports. The benefit of Deprexis in individuals with depression is uncertain. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with amblyopia who receive Luminopia, the evidence includes one RCT and an open-label pilot study. Studies reviewed lacked long-term follow-up and comparisons with other methods of treatment. A randomized, controlled trial with comparisons to conventional treatments would provide the strongest evaluation of efficacy. In addition, the pilot study did not evaluate durability of benefit with the therapeutic. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with chronic insomnia who receive Somryst®, the evidence includes one RCT. The reviewed study lacked long-term follow-up, comparators and larger participant size. The benefit of Somryst in individuals with chronic insomnia is uncertain. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have urinary incontinence (women) who receive biofeedback with pelvic floor muscle training (PFMT) using a motion-based digital intravaginal device (e.g., leva), the evidence includes randomized controlled trials (RCTs) and a longitudinal analysis. Relevant outcomes are symptoms, functional outcomes, and quality of life. A comparative effectiveness review did not find a statistically significant difference incontinence rates when individuals received PFMT with or without biofeedback. There is a lack of consistent evidence from well-designed trials that biofeedback effectively treats urinary incontinence. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements 

American Urological Association et al

The 2024 American Urological Association/Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction guideline on overactive bladder includes biofeedback as an example of non-invasive therapies. Although they make no specific recommendations for biofeedback, they state, "Clinicians may offer select non-invasive therapies to all patients with OAB." However, they caution, "While safety profiles are excellent across modalities, with few adverse effects and a high risk-benefit ratio, all non-invasive therapies do not have equivalent efficacy and the evidence base is highly variable. Most non-invasive therapies require long-term patient compliance to maintain a durable effect and patients should be counselled as such before embarking on a course of a potentially lifelong therapy."

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS: 

Freespira, Canary Breathing System; NightWare, PTSD, Deprexis, Luminopia, Somryst, insomnia, LEVA, urinary incontinence, Mightier Program

APPROVED BY GOVERNING BODIES:

Digital health technologies that meet the current scope of the review are shown in Table 1.

Table 1. Examples of Prescription Digital Health Applications 

EtCO₂: exhaled carbon dioxide; FDA: U.S. Food and Drug Administration; PTSD: post-traumatic stress disorder; RR: respiration rate; SaMD: software as a medical device.

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

CURRENT CODING: 

CPT Codes: 

There are no specific CPT codes

HCPCS Codes:

REFERENCES: 

1. American Psychiatric Association. (2013). Trauma- and stressor related disorders. In Diagnostic and statistical manual of psychiatric disorders (5th edn). //doi. org/10.1176/ appi.books.9780890425596. dsm07
2. Beevers CG, Pearson R, Hoffman JS, Foulser AA, Shumake J, Meyer B. Effectiveness of an internet intervention (deprexis) for depression in a United States adult sample: a parallel-group pragmatic randomized controlled trial. J Consult Clin Psychol. 2017;85(4):367-380. doi:10.1037/ccp0000171.
3. Berger T. Evaluating an e-mental health program ("deprexis") as adjunctive treatment tool in psychotherapy for depression: results of a pragmatic randomized controlled trial. J Affect Disord. 2017;227:455-462.
4. Berger T, Hämmerli K, Gubser N, et al. Internet-based treatment of depression: a randomized controlled trial comparing guided with unguided self-help. Cogn Behav Ther. 2011;40(4):251-266
5. Berger T, Krieger T, Sude K, et al. Evaluating an e-mental health program (“deprexis”) as adjunctive treatment tool in psychotherapy for depression: results of a pragmatic randomized controlled trial. J Affect Disord. 2018;227:455-462.
6. Bücker L, Bierbrodt J, Hand I, Wittekind C, Moritz S. Effects of a depression-focused internet intervention in slot machine gamblers: a randomized controlled trial [published correction appears in PLoS One. Aug 23, 2018;13(8):e0203145]. PLoS
7. Cameron AP, Chung DE, Dielubanza EJ, et al. The AUA/SUFU Guideline on the Diagnosis and Treatment of Idiopathic Overactive Bladder. J Urol. Jul 2024; 212(1): 11-20.
8. Davenport ND, Werner JK. A randomized sham-controlled clinical trial of a novel wearable intervention for trauma-related nightmares in military veterans. J Clin Sleep Med. Feb 01 2023; 19(2): 361-369.
9. De novo classification request for Nightware kit (Apple iphone, Apple watch, Apple iphone charging cable, Apple watch charging cable). Available at www.accessdata.fda.gov/cdrh_docs/reviews/DEN200033.pdf.
10. Deacon B, Lickel J, Abramowitz JS. Medical utilization across the anxiety disorders. J Anxiety Disord. 2008; 22(2): 344-50.
11. Driessen E, Hollon SD. Cognitive behavioral therapy for mood disorders: efficacy, moderators and mediators. Psychiatr Clin North Am. 2010;33(3):537-555.
12. International Medical Device Regulators Forum. Software as a Medical Device (SaMD): Key Definitions. 2013. www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-definitions-140901.pdf.
13. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
14. Kaplan A, Mannarino AP, Nickell PV. Evaluating the Impact of Freespira on Panic Disorder Patients' Health Outcomes and Healthcare Costs within the Allegheny Health Network. Appl Psychophysiol Biofeedback. Sep 2020; 45(3): 175-181.
15. Kellner M, Muhtz C, Nowack S, et al. Effects of 35% carbon dioxide (CO2) inhalation in patients with post-traumatic stress disorder (PTSD): A double-blind, randomized, placebo-controlled, cross-over trial. J Psychiatr Res. Jan 2018; 96: 260-264.
16. Klein JP, Berger T, Schröder J, et al. Effects of a psychological internet intervention in the treatment of mild to moderate depressive symptoms: results of the EVIDENT study, a randomized controlled trial. Psychother Psychosom. 2016;85(4):218-228. doi:10.1159/000445355.
17. Meuret AE, Wilhelm FH, Ritz T, et al. Feedback of end-tidal pCO2 as a therapeutic approach for panic disorder. J Psychiatr Res. Jun 2008; 42(7): 560-8.
18. Meyer B, Bierbrodt J, Schröder J, et al. Effects of an internet intervention (deprexis) on severe depression symptoms: Randomized controlled trial. Internet Interventions. 2015;2(1):48-59. doi:10.1016/j.invent.2014.12.003.
19. Meyer B, Berger T, Caspar F, et al. Effectiveness of a novel integrative online treatment for depression (deprexis): randomized controlled trial. J Med Internet Res. 2009;11(2):e15.
20. Moritz S, Schilling L, Hauschildt M, Schröder J, Treszl A. A randomized controlled trial of internet-based therapy in depression. Behav Res Ther. 2012;50(7-8):513-521. doi:10.1016/j.brat.2012.04.006.
21. Morgenthaler TI, Auerbach S, Casey KR, et al. Position Paper for the Treatment of Nightmare Disorder in Adults: An American Academy of Sleep Medicine Position Paper. J Clin Sleep Med. Jun 15 2018; 14(6): 1041-1055.
22. Muhtz C, Yassouridis A, Daneshi J, et al. Acute panicogenic, anxiogenic and dissociative effects of carbon dioxide inhalation in patients with post-traumatic stress disorder (PTSD). J Psychiatr Res. Jul 2011; 45(7): 989-93. 
23. National Institute for Health and Care Excellence (NICE). Evidence standards framework for digital health technologies. 2021. nice.org.uk/corporate/ecd7/chapter/section-a-evidence-for-effectiveness-standards.
24. Ostacher MJ, Fischer E, Bowen ER, et al. Investigation of a Capnometry Guided Respiratory Intervention in the Treatment of Posttraumatic Stress Disorder. Appl Psychophysiol Biofeedback. Dec 2021; 46(4): 367-376.
25. Ritterband LM, Thorndike FP, Ingersoll KS, Lord HR, Gonder-Frederick L, Frederick C, Quigg MS, Cohn WF, Morin CM. Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention With 1-Year Follow-up: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Jan 1;74(1):68-75. doi: 10.1001/jamapsychiatry.2016.3249.
26. Schröder J, Brückner K, Fischer A, et al. Efficacy of a psychological online intervention for depression in people with epilepsy: a randomized controlled trial. Epilepsia. 2014;55(12):2069-2076.
27. Tolin DF, McGrath PB, Hale LR, et al. A Multisite Benchmarking Trial of Capnometry Guided Respiratory Intervention for Panic Disorder in Naturalistic Treatment Settings. Appl Psychophysiol Biofeedback. Mar 2017; 42(1): 51-58.
28. Weinstein, MM, Dunivan, G, Guaderrama, NM, Richter, HE. Digital Therapeutic Device for Urinary Incontinence: A Randomized Controlled Trial [published online ahead of print, 2022 March 10]. Obstet Gynecol.
29. Weinstein MM, Dunivan G, Guaderrama NM, et al. Digital Therapeutic Device for Urinary Incontinence: A Randomized Controlled Trial.Obstet Gynecol. Apr 01 2022; 139(4): 606-615.
30. Weinstein MM, Dunivan GC, Guaderrama NM, et al. Digital Therapeutic Device for Urinary Incontinence: A Longitudinal Analysis at 6and 12 Months. Obstet Gynecol. Jan 01 2023; 141(1): 199-206.
31. Xiao S, Angjeli, MS et al. Randomized Controlled Trial of a Dichoptic Digital Therapeutic for Amblyopia. Ophthalmology. 2022; 129 (1), 77-85.
32. Xio S, Gaier ED, et al. Digital therapeutic improves visual acuity and encourages high adherence in amblyopic children in open-label pilot study Journal of AAPOS 2021; 25 (2):87. E1-87.E6.

POLICY HISTORY: 

Medical Policy Panel, April 2023

Medical Policy Group: April 2023 (6): New medical policy. Devices previously investigational per MP 495 Investigational Criteria.

Medical Policy Administration Committee: May 2023.

Available for Comment: May 1, 2023 through June 15, 2023

Medical Policy Group, July 2023 (6): All information regarding Deprexis transferred from MP 736 Digital Health Therapies for Substance Abuse.

Medical Policy Group, September 2023 Quarterly HCPCS Coding Update. A9292 added to Current Coding section. Updates to Key Points, Key Words, Governing Bodies and References to include Luminopia.

Medical Policy Group, October 2023 (6): Updates to Key Points, Governing Bodies, Key Words and References to include Somryst®.

Medical Policy Group, March 2024: April HCPCS Coding Update. S9002 added to Current Coding section.

Medical Policy Panel, July 2024

Medical Policy Group, July 2024 (6): Updates to Policy statement to expand non-covered indication examples, Key Points, Governing Bodies, Key Words and References.

Medical Policy Group, October 2024 (6): Updates to Key Points, Practice Guidelines and References to include information regarding the leva device.

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.