FDA-cleared, first-line CBT-I for Medicare patients with insomnia

SleepioRx¹ is an FDA-cleared digital treatment for insomnia disorder delivering guideline-recommended cognitive behavioral therapy (CBT) through video and audio lessons in a mobile app. Designed by sleep experts, the treatment helps patients understand unhealthy patterns and address the thoughts and behaviors that sustain insomnia. CBT techniques delivered in an engaging and interactive format help patients overcome insomnia, quickly.
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1. SleepioRx is a digital therapeutic intended for the treatment of chronic insomnia/insomnia disorder as an adjunct to usual care in patients aged 18 and older. SleepioRx is a prescription device delivering Cognitive Behavioral Therapy for Insomnia (CBT-I) and can be made available on the order of a licensed healthcare provider. Patients should read the instructions for use for full information.

You can place an order and start distributing SleepioRx to your qualifying patients in three simple steps:
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Step 1: Big Health provides providers with a website for ordering, along with unique access codes. Print and digital referral materials are also available if needed.
Step 2: The provider identifies qualifying patients, explains SleepioRx, and enters a unique access code and the patient's phone number on the website.
Step 3: The patient receives a text message with instructions for accessing, downloading and signing up for SleepioRx.

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. While we are actively engaging other insurance carriers to expand coverage, these DMHT codes are not a guarantee of reimbursement.

Licensed providers who are able to offer behavioral therapy or behavioral health care within their scope of practice can order SleepioRx and bill for the codes.This includes the following practitioners:

- Psychiatrists & other doctors (MDs, DOs)
- Clinical psychologists
- Clinical social workers (LCSWs, LICSWs)
- Advanced practice nurses/Nurse practitioners (NPs)
- Physician assistants (PAs)
- Marriage & family therapists (LMFTs)
- Mental health counselors
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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.

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 have some form of supplemental coverage which may cover all or part of the coinsurance depending on plan policies.1 Medicare Advantage, Commercial, and Medicaid patient cost-share obligations are dependent on specific plan policies.
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1. Kaiser Family Foundation, September 2024