Digital Therapeutics Form

Description

Digital therapeutics (DTx) are prescription or nonprescription clinical interventions delivered directly to individuals via software to treat, manage, or prevent health conditions. DTx may be used alone or in combination with other interventions, such as medication or a medical device. While these technologies do not replace a health care provider, DTx are being explored as a method for increasing agility in personalized health care decisions in ways that may not require traditional office visits. Although the field is evolving, prescription DTx undergo clinical trials and are held to similar standards of safety and efficacy as traditional medical treatments.

Convenience and accessibility have been suggested as benefits of DTx, along with increasing an individual’s engagement in their own health outcomes. An example of practical use of a DTx may be the ability to adjust medication or treatment in between regular office visits. Potential concerns regarding DTx include data privacy,

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Digital Therapeutics Effective Date:

06/22/2023

Revision Date:

06/22/2023

Review Date:

03/01/2023

Policy Number:

HUM-0565-012

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

oversight/regulation, and quality. DTx may involve the use of a single technology or a combination of technologies, such as those described below.

Artificial intelligence (AI)

combines computer systems, databases and advanced algorithms to imitate human abilities, such as decision-making and problem-solving. Common everyday uses include customer service, facial and voice recognition, and recommendation/search engines. AI is being explored for many clinical uses, such as detection (blood glucose level, heart arrhythmia, seizure) or the diagnosis of illness based on medical imaging or histopathology (changes in cells or tissues caused by disease). AI is being used to augment the analysis of facial phenotypes (observable characteristics or traits of a disease) associated with genetic syndromes.

Augmented reality (AR) and virtual reality (VR)

use computer simulation and modeling to allow an individual to interact with an artificial three-dimensional (3D) environment. AR mixes simulated digital imagery with the real world and is seen through a camera or display, such as a smartphone or head-mounted or heads-up display (HMD or HUD). Typically, the individual wears equipment (gloves, goggles, headset) that provides sensory feedback to the computer based on the wearer’s movements. AR has been used as a surgical training tool for medical students and is being explored to overlay images on to a patient and guide a surgeon’s technique during surgery. VR is being explored as an adjunctive treatment tool for cognitive rehabilitation, enhanced physical therapy, memory improvement and pain reduction. Mental health VR applications under study include augmenting therapy for anxiety, depression, phobias and post-traumatic stress disorder. For more information on specific medical devices that incorporate AR and VR, please see the US Food & Drug Administration (FDA) website.

Mobile applications (apps, mobile apps)

are software programs designed specifically for use on mobile devices such as smartphones. Mobile health (mHealth) apps offer a wide range of personal health management options for both wellness and chronic conditions (eg, fitness tracking, meditation guidance, stress reduction, weight management).

Mobile medical apps (MMA) are medical devices that are mobile apps, meet the definition of a medical device, and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device. Both MMAs and mHealth apps may incorporate games, or use game-like features designed to encourage participation in therapeutic interventions as well as establish and maintain certain desired health behaviors.

Digital Therapeutics Effective Date:

06/22/2023

Revision Date:

06/22/2023

Review Date:

03/01/2023

Policy Number:

HUM-0565-012

Page:

3 of 12

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

The FDA Digital Health Center of Excellence regulates software as a medical device (SaMD) along with artificial intelligence and machine learning (AI/ML)-enabled devices. The FDA review process focuses on software functions (including mobile apps) that meet the definition of a medical device and may be deployed on mobile platforms, other general-purpose computing platforms, or in the function or control of a hardware device. To date, more than 500 such devices have been reviewed; for information on approval, authorization or clearance please see the FDA website.

Coverage Determination

Humana recognizes that the field of digital therapeutics is rapidly changing and that other technologies may become available.

For information regarding digital therapeutic technologies used in conjunction with specific devices, diagnostic methods, procedures or treatments, refer to the applicable medical coverage policy. If no applicable policy exists, use the following coverage guidance.

Humana members may NOT be eligible under the Plan for the following technologies:

• Artificial Intelligence: When used in conjunction with, and to enhance another device or treatment for which there is no applicable Medical Coverage Policy or Reimbursement Policy, NOT COVERED — experimental/investigational* When proposed for direct-to-consumer use, NOT COVERED experimental/investigational*

Digital Therapeutics Effective Date:

06/22/2023

Revision Date:

06/22/2023

Review Date:

03/01/2023

Policy Number:

HUM-0565-012

Page:

4 of 12

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Mobile Health Apps: NOT COVERED - over-the-counter (OTC)**
• Mobile Medical Apps: When used in conjunction with, and/or to enhance another device or treatment for which a Medical Coverage Policy exists (e.g., MMAs via smartphone to interface with monitoring or treatment devices such as blood pressure, cardiac or glucose monitoring, insulin pumps, nonimplantable muscle stimulators, spinal cord stimulators), refer to that policy for coverage guidance.

• Experimental/investigational: When used in conjunction with, and to enhance another device or treatment, NOT COVERED — experimental/investigational* When prescribed for direct-to-consumer or stand-alone use, NOT COVERED — not medically necessary If available without prescription, NOT COVERED — OTC**

• Virtual Reality: When used in conjunction with, and/or to enhance another device or treatment for which a Medical Coverage Policy exists (e.g., VR-assisted gait training/physical therapy, digital amblyopia therapy) refer to that policy for coverage guidance.
• When used in conjunction with, and to enhance another device or treatment for which there is no applicable Medical Coverage Policy, NOT COVERED — experimental/investigational*

*Experimental/investigational means not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.
Digital Therapeutics Effective Date: 06/22/2023
Revision Date: 06/22/2023
Review Date: 03/01/2023
Policy Number: HUM-0565-012
Page: 5 of 12
Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
**Although they may be prescribed by a health care practitioner, these technologies may be available without a prescription and may be obtained over-the-counter (OTC) and are therefore generally excluded in the certificate. In the absence of a certificate exclusion for OTC items, these are considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for laptop computers, tablet devices (e.g., iPad, Kindle), smartphones, desktop computers or personal digital assistants (PDA), as they are not primarily medical in nature and do not meet the contractual definition of durable medical equipment (DME).

Additional information about AI, AR/VR, DTx, mHealth apps and MMAs may be found from the following websites:
Background
National Library of Medicine • US Food & Drug Administration
Medical Alternatives
Physician consultation is advised to make an informed decision based on an individual’s health needs.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.