Somryst – Prescription Digital Therapeutic for Treatment of Chronic Policy Number: PG0499 ADVANTAGE | ELITE | HMO Last Review: 08/04/2021

INDIVIDUAL MARKETPLACE | PROMEDICA MEDICARE PLAN | PPO GUIDELINES  This policy does not certify benefits or authorization of benefits, which is designated by each individual policyholder terms, conditions, exclusions and limitations contract. It does not constitute a contract or guarantee regarding coverage or reimbursement/payment. Self-Insured group specific policy will supersede this general policy when group supplementary plan document or individual plan decision directs otherwise.  Paramount applies coding edits to all medical claims through coding logic software to evaluate the accuracy and adherence to accepted national standards.  This medical policy is solely for guiding medical necessity and explaining correct procedure reporting used to assist in making coverage decisions and administering benefits.

SCOPE X Professional _ Facility

DESCRIPTION Insomnia is a sleep disorder with symptoms that include difficulty falling asleep, staying asleep, or waking too early. Chronic insomnia is defined as insomnia persisting for > 1 month. Causes are attributed to stress, travel, work schedule, poor sleep habits, and eating too much before bedtime. Mental health disorders of anxiety and depression may be contributors. Use of some antidepressants, , hypertensive medications, and over-the- counter medications containing stimulants may interfere with sleep. Alcohol, caffeine, and nicotine use may also interfere with sleep. Medical conditions associated with insomnia include chronic pain, cancer, diabetes, cardiac , asthma, reflux disease, hyperthyroidism, Parkinson’s, and Alzheimer’s disease. Sleep-related disorders include sleep apnea and restless legs syndrome. Insomnia is more common with advancing age.

Treatments for insomnia include improving sleep-related habits (i.e., sleep hygiene), cognitive behavioral therapy, or medications. Insomnia caused by a medical condition may be resolved by treating the underlying condition.

Prescription digital therapeutics (PDTs) are a new class of software-based medical devices. Mobile medical applications (MMAs) may fill gaps that currently exist in conventional treatment programs by enabling patients to better manage their care and track their health and wellness activities and by providing access to information and communications with healthcare providers. Somryst is the first available PDT for the treatment of chronic insomnia. Somryst is a prescription-only digital therapeutic intended to provide a neurobehavioral intervention to patients 22 years of age and older with chronic insomnia. Somryst treats patients with chronic insomnia by improving a patient’s insomnia symptoms.

 Somryst is a 9-week PDT for chronic insomnia. Somryst can be used on a mobile device, such as a smartphone or tablet. Somryst is available by prescription only. A licensed Health Care Provider (HCP) must prescribe Somryst, and the use of Somryst should be undertaken only under the supervised care of a Health Care Provider.

 Somryst delivers digital Cognitive Behavioral Therapy for Insomnia (CBT-I) therapeutic content. CBT-I is a neurobehavioral treatment, which focuses on addressing the maladaptive behaviors, routines, and dysfunctional thoughts that perpetuate sleep problems, regardless of the original source of the sleep problem.

PG0499 – 08/04/2021  Somryst includes a daily sleep diary that is completed by the patient. The clinician-facing dashboard includes information about patient use of the device, the Insomnia Severity Index, the Patient Health Questionnaire, and sleep metrics derived from sleep diaries.

 Somryst may be downloaded to an iPhone, iPad, or Android phone or tablet and is compatible with mobile devices with an iOS version 9.0 or higher or an Android version 5.0 or higher. Somryst has patient- and clinician-facing dashboards.

POLICY HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan, Advantage

Computer Based Treatment for Cognitive Behavioral Therapy (CBTCBT) such as Somryst is experimental/investigational/unproven and therefore Not Covered.

Non-participating providers are required to obtain prior authorization BEFORE any services are rendered.

COVERAGE CRITERIA HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan, Advantage Computer Based Treatment for Cognitive Behavioral Therapy such as Somryst is Noncovered as the treatment is unproven, the safety and effectiveness of this technology cannot be completed at this time without a sufficient quantity of published literature/studies. There is an insufficient quantity of published, peer-reviewed, human clinical data to evaluate Somryst interactive digital therapy for treatment of Chronic Insomnia in a health technology assessment (HTA).

CODING/BILLING INFORMATION The inclusion or exclusion of a code in this section does not necessarily indicate coverage. Codes referenced in this clinical policy are for informational purposes only. Codes that are covered may have selection criteria that must be met. Payment for supplies may be included in payment for other services rendered. CPT CODE The following list, not all-inclusive, of potential Healthcare Common Procedure Coding System (Current Procedural Terminology) codes are not covered when utilized for Computer Based Treatment for Cognitive Behavioral Therapy such as Somryst. 90832 Psychotherapy, 30 min with patient 90885 Psychiatric evaluation of hospital records, other psychiatric reports, psychometric and/or Not observed projective tests, and other accumulated data for medical diagnostic purposes 90887 Interpretation or explanation of results of psychiatric, other medical examinations and procedures, or other accumulated data to family or other responsible persons, or advising them how to assist patient 90889 Preparation of report of patient’s psychiatric status, history, treatment, or progress (other than for legal or consultative purposes) for other individuals, agencies, or insurance carriers 96105 Assessment of aphasia (includes assessment of expressive and receptive speech and language function, language comprehension, speech production ability, reading, spelling, and writing, eg, by Boston Diagnostic Aphasia Examination), with interpretation and report per hour 96110 Developmental screening (eg, developmental milestone survey, speech, and language delay screen), with scoring and documentation, per standardized instrument 96116 Neurobehavioral status exam (clinical assessment of thinking, reasoning and judgment, eg, acquired knowledge, attention, language, memory, planning and problem solving, and visual spatial abilities) by physician or other qualified health care professional, both face-to-face time with the patient and time interpreting test results and preparing the report; first hour 96127 Brief emotional/behavioral assessment (eg, depression inventory, attention-deficit/hyperactivity

PG0499 – 08/04/2021 disorder scale), with scoring and documentation, per standardized instrument 96130 Psychological testing evaluation services by a physician or other qualified health care professional, including integration of patient data, interpretation of standardized test results and clinical data, clinical decision making, treatment planning and report, and interactive feedback to the patient, family member(s) or caregiver(s), when performed; first hour 96138 Psychological or neuropsychological test administration and scoring by a technician, 2 or more tests, any method; first 30 min 96146 Psychological or neuropsychological test administration, with single automated, standardized instrument via electronic platform, with automated result only 96160 Administration of a patient-focused health risk assessment instrument (eg, health hazard appraisal), with scoring and documentation, per standardized instrument 96161 Administration of a caregiver-focused health risk assessment instrument (eg, depression inventory) for the benefit of the patient, with scoring and documentation, per standardized instrument 99091 Collection and interpretation of physiologic data (eg, electrocardiogram, blood pressure, and glucose monitoring) digitally stored and/or transmitted by the patient and/or caregiver to the physician or other qualified health care professional, qualified by education, training, and licensure/regulation (when applicable), requiring a minimum of 30 min of time, every 30 days 99358 Prolonged evaluation and management service before and/or after direct patient care; first hour 99367 Medical team conference with interdisciplinary team of health care professionals, patient, and/or family not present, 30 min or more; participation by physician 99401 Preventive medicine counseling and/or risk factor reduction intervention(s) provided to an individual (separate procedure); approximately 15 min 99406 Smoking and tobacco use cessation counseling visit; intermediate, greater than 3 min, up to 10 min 99408 Alcohol and/or substance (other than tobacco) abuse structured screening (eg, Alcohol Use Disorders Identification Test, Drug Abuse Screening Test) and brief intervention services; 15 to 30 min 99429 Unlisted preventive medicine service 99446 Interprofessional telephone/internet/electronic health record assessment and management provided by a consultative physician, including a verbal and written report to the patient’s treating/requesting physician or other qualified health care professional; 5-10 min of medical consultative discussion and review 99453 Remote monitoring of physiologic parameter(s), for example, weight, blood pressure, pulse oximetry, and respiratory flow rate, initial; setup and patient education on use of equipment 99457 Remote physiologic monitoring treatment management services, clinical staff/physician/other qualified health care professional time in a calendar month requiring interactive communication with the patient/caregiver during the month; first 20 minutes 99483 Assessment of and care planning for a patient with cognitive impairment, requiring an independent historian, in the office or other outpatient, home or domiciliary or rest home, with all of the following required elements: cognition-focused evaluation, including a pertinent history and examination; medical decision making of moderate or high complexity; functional assessment (eg, basic and instrumental activities of daily living), including decision-making capacity; use of standardized instruments for staging of (eg, functional assessment staging test, clinical dementia rating); medication reconciliation and review for high-risk medications; evaluation for neuropsychiatric and behavioral symptoms, including depression, including use of standardized screening instrument(s); evaluation of safety (eg, home), including motor vehicle operation; identification of caregiver(s), caregiver knowledge, caregiver needs, social supports, and the willingness of caregiver to take on caregiving tasks; development, updating or revision, or review of an Advance Care Plan; creation of a written care plan, including initial plans to address any neuropsychiatric symptoms, neurocognitive symptoms, functional limitations, and referral to community resources as needed (eg, rehabilitation services, adult day programs, and support groups) shared with the patient and/or caregiver with initial education and support. Typically, 50 min are spent face to face with the patient and/or family or caregiver 99484 Care management services for behavioral health conditions, at least 20 min of clinical staff time, directed by a physician or other qualified health care professional, per calendar month, with the

PG0499 – 08/04/2021 following required elements: initial assessment or follow-up monitoring, including the use of applicable validated rating scales; behavioral health care planning in relation to behavioral/psychiatric health problems, including revision for patients who are not progressing or whose status changes; facilitating and coordinating treatment, such as psychotherapy, pharmacotherapy, counseling and/or psychiatric consultation; continuity of care with a designated member of the care team 99487 Complex chronic care management services, with the following required elements: multiple (2 or more) chronic conditions expected to last at least 12 months or until the death of the patient, chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline, establishment or substantial revision of a comprehensive care plan, moderate- or high-complexity medical decision making; 60 min of clinical staff time directed by a physician or other qualified health care professional, per calendar month 99490 Chronic care management services, at least 20 min of clinical staff time directed by a physician or other qualified health care professional, per calendar month, with the following required elements: multiple (2 or more) chronic conditions expected to last at least 12 months or until the death of the patient; chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline; comprehensive care plan established, implemented, revised, or monitored 99492 Initial psychiatric collaborative care management, first 70 min in the first calendar month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional, with the following required elements: outreach to and engagement in treatment of a patient, directed by the treating physician or other qualified health care professional; initial assessment of the patient, including administration of validated rating scales, with the development of an individualized treatment plan; review by the psychiatric consultant, with modifications of the plan if recommended; entering patient in a registry and tracking patient follow-up and progress using the registry, with appropriate documentation, and participation in weekly caseload consultation with the psychiatric consultant; provision of brief interventions, using evidence-based techniques, such as behavioral activation, motivational interviewing, and other focused-treatment strategies 99494 Initial or subsequent psychiatric collaborative care management, every additional 30 min in a calendar month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional (listed separately, in addition to code for primary procedure) 99495 Transitional Care Management Services, with the following required elements: communication Not observed (direct contact, telephone, and electronic) with the patient and/or caregiver within 2 business days of discharge. Medical decision making of at least moderate complexity during the service period. Face-to-face visit, within 14 calendar days of discharge 99499 Unlisted evaluation and management service T1505 Electronic medication compliance management device, includes all components and accessories, not otherwise classified

Paramount reserves the right to review and revise our policies periodically when necessary. When there is an update, we will publish the most current policy to https://www.paramounthealthcare.com/services/providers/medical-policies/ .

REVISION HISTORY EXPLANATION ORIGINAL EFFECTIVE DATE: 08/04/2021 Date Explanation & Changes  Policy created to industry standards 08/04/2021  Computer Based Treatment for Cognitive Behavioral Therapy (CBTCBT) such as Somryst is experimental/investigational/unproven and therefore Not Covered.

PG0499 – 08/04/2021 REFERENCES/RESOURCES Centers for Medicare and Medicaid Services, CMS Manual System and other CMS publications and services

Ohio Department of Medicaid

American Medical Association, Current Procedural Terminology (CPT®) and associated publications and services

Centers for Medicare and Medicaid Services, Healthcare Common Procedure Coding System, HCPCS Release and Code Sets

U.S. Preventive Services Task Force, http://www.uspreventiveservicestaskforce.org/ Industry Standard Review

Hayes, Inc.

Industry Standard Review

PG0499 – 08/04/2021