Digital Health Technologies: Diagnostic Applications

POLICY NUMBER

A.3.03.01

DESCRIPTION

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 policy includes only those digital technologies that are intended to be used for diagnostic application (detecting the presence or absence of a condition, the risk of developing a condition in the future, or treatment response [beneficial or adverse]) and meet the following 3 criterion- 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 either through the de novo premarket process or 510(k) process or pre-market approval and 3) Must be prescribed by a healthcare provider.

Autism Spectrum Disorder

Autism spectrum disorder (ASD) is a biologically based neurodevelopmental disorder characterized by persistent deficits in social communication and social interaction and restricted, repetitive patterns of behavior, interests, and activities. ASD can range from mild social impairment to severely impaired functioning; as many as half of individuals with autism are non-verbal and have symptoms that may include debilitating intellectual disabilities, inability to change routines, and severe sensory reactions. The American Psychiatric Association’s Diagnostic and Statistical Manual, Fifth Edition (DSM-5) provides standardized criteria to help diagnose ASD.

Diagnosis of ASD in the United States generally occurs in two steps: developmental screening followed by comprehensive diagnostic evaluation if screened positive. American Academy of Pediatrics (AAP) recommends general developmental screening at 9, 18 and 30 months of age and ASD specific screening at 18 and 24 months of age. Diagnosis and treatment in the first few years of life can have a strong impact on functioning as it allows for treatment during a key window of developmental plasticity. However, early diagnosis in US remains an unmet need even though studies have demonstrated a temporal trend of decreasing mean ages at diagnosis over time. According to a 2020 study by Autism and Developmental Disabilities Monitoring (ADDM) Network, an active surveillance system that provides estimates of ASD in the US, reported median age of earliest known ASD diagnosis ranged from 36 months in California to 63 months in Minnesota.

Scope of Policy

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

1. Software used in the manufacture or maintenance of a medical device (example 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 (example 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) (example, 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 policy includes only those digital technologies that are intended to be used for diagnostic application (detecting presence or absence of a condition, the risk of developing a condition in the future, or treatment response [beneficial or adverse]) and meet the following 3 criterion-

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 either through the de novo premarket 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

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

Digital health technologies that meet the current scope of this policy are shown in the table below.

Digital Health Technology for Diagnostic Applications

FDA: U.S. Food and Drug Administration

POLICY

Prescription digital health technologies for diagnostic application that have received clearance for marketing by the U.S. Food and Drug Administration as a diagnostic aid for autism spectrum disorder (Canvas Dx) are considered investigational.

POLICY EXCEPTIONS

Federal 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.

POLICY GUIDELINES

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 HISTORY

08/01/2023: New policy added. Approved by the Medical Policy Advisory Committee.

09/22/2023: Policy reviewed; no changes.

08/12/2024: Policy reviewed; no changes.

12/20/2024: Code Reference section updated to add new HCPCS codes G0552, G0553, and G0554 effective 01/01/2025.

SOURCE(S)

Blue Cross Blue Shield Association policy # 3.03.01

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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