SleepioRx and DaylightRx are FDA-cleared digital treatments for insomnia disorder and generalized anxiety disorder, respectively, delivering guideline-recommended cognitive behavioral therapy (CBT) through video and audio lessons in mobile apps. Designed by sleep and anxiety experts, the treatments help patients understand unhealthy patterns and address the thoughts and behaviors that sustain insomnia and anxiety. CBT techniques delivered in an engaging and interactive format help patients overcome insomnia and anxiety, quickly.
Any patient aged 18+ with an insomnia (SleepioRx) or patient aged 22+ with an anxiety (DaylightRx) complaint who understands conversational English, has a smartphone, and is comfortable with technology is a good candidate. SleepioRx and DaylightRx can complement other treatments and are effective across all adult age groups, including older adults up to those in their late 80s.
SleepioRx has been tested to the highest standards of clinical evidence across 16 randomized controlled trials (RCTs). In a placebo RCT, 76% of SleepioRx patients experienced a clinically significant change in their Sleep Efficiency (SE>80%) by post-treatment, as compared to 29% for placebo (Imagery Relief Therapy) and 18% for TAU (Treatment As Usual). Data suggest benefits are maintained up to 1 year after starting SleepioRx.
[Add clinical evidence for DaylightRx]
In accordance with the FDA-cleared indications for use, SleepioRx and DaylightRx are intended to be provided adjunct to usual care. Therefore, SleepioRx and DaylightRx can be provided for use by individuals who are receiving medication to manage their insomnia and anxiety.
Contact our team by filling out this short form [link to demo request page] and a team member will get in touch with more information and to discuss next steps.
The Centers for Medicare & Medicaid Services (CMS) has finalized three new Digital Mental Health Treatment (DMHT) codes in the Calendar Year (CY) 2025 Medicare Physician Fee Schedule as of January 1, 2025, allowing providers a reimbursement opportunity for prescribing DMHTs like SleepioRx and DaylightRx to Medicare patients. We are actively engaging other insurance carriers to expand coverage.
G0552: Supply of digital mental health treatment device and initial education and onboarding, per course of treatment that augments a behavioral therapy plan.
G0553: First 20 minutes of monthly treatment management services directly related to the patient’s therapeutic use of the digital mental health treatment (DMHT) device that augments a behavioral therapy plan, physician/other qualified health care professional time reviewing information related to the use of the DMHT device, including patient observations and patient-specific inputs in a calendar month and requiring at least one interactive communication with the patient/caregiver during the calendar month.
G0554: Each additional 20 minutes of monthly treatment management services directly related to the patient’s therapeutic use of the digital mental health treatment (DMHT) device that augments a behavioral therapy plan, physician/other qualified health care professional time reviewing information related to the use of the DMHT device, including patient observations and patient-specific inputs in a calendar month and requiring at least one interactive communication with the patient/caregiver during the calendar month. (List separately in addition to HCPCS code G0553).
Licensed providers who offer behavioral therapy or behavioral health care within their scope can order these products and bill for the codes. For Medicare, eligible practitioners include:
- Psych iatrists & other doctors (MDs, DOs)
- Clinical psychologists
- Clinical social workers
- Clinical nurse specialists
- Nurse practitioners
- Physician assistants
- Marriage & family therapists
- Mental health counselors
Check commercial payer policies for restrictions. The billing practitioner or a colleague should oversee patient care and adjust treatment as needed. They may also supervise non-qualifying practitioners in providing these services.
DMHT products are billed ‘incident to’ a provider’s services, requiring the provider to purchase a license, furnish it to the patient, and submit a claim for reimbursement. Costs must be incurred by the provider, as free products aren’t reimbursed. This mirrors the ‘buy and bill’ model for non-self-administered drugs and physician-furnished medical supplies.
Only DMHT devices approved or cleared by FDA under 21 CFR 882.5801 are currently eligible for payment under the new codes. Classification 882.5801 is an umbrella regulation for “Computerized behavior therapy for psychiatric disorders” and includes special controls requiring clinical evidence. Seven DMHTs, including SleepioRx and DaylightRx, have been cleared by the FDA under this classification to date, and therefore qualify for reimbursement.
Like other covered services, patients may have a cost share according to their specific plan policies. Traditional Medicare requires a 20% coinsurance for all practitioner services, including these codes, though nearly 90% of people had some form of supplemental coverage which may cover all or part of this coinsurance depending on plan policies. Medicare Advantage, Commercial, and Medicaid patient cost-share obligations are dependent on specific plan policies.
CMS has pointed out that individuals with mental health or behavioral health conditions may have more than one co-occurring condition and so has not set any limits on the number of DMHT devices that can be billed concurrently for Medicare beneficiaries. Please refer to any relevant commercial payer medical policies for any specific restrictions for their plans.