What Are Prescription Digital Therapeutics? Apps Your Doctor Can Prescribe

Your doctor hands you a prescription, but instead of a pill bottle, you get an access code for an app. That is the idea behind prescription digital therapeutics, often shortened to PDTs. They sit in a strange middle ground: software you use on your phone, regulated by the FDA like a medical device, and prescribed by a clinician like a medication.

If you have been offered one, or you are a clinician wondering whether they are worth the paperwork, this guide explains what they are, how they get through the FDA, what conditions they treat and the big question for most people: will insurance pay?

What makes a digital therapeutic “prescription”

A prescription digital therapeutic is software intended to treat a medical condition, with a specific FDA-cleared or authorized claim, that can only be used under a clinician’s order.

That separates it from the thousands of wellness apps in the app stores. A meditation app can say it helps you relax. A prescription digital therapeutic can make a specific treatment claim for a diagnosed condition because the FDA reviewed evidence for that claim.

Here is how the main categories compare:

Most PDTs are designed as an adjunct, meaning they add to existing treatment such as therapy or medication rather than replace it.

How the FDA clears these apps

Software that treats disease counts as a medical device under federal law, so it goes through the FDA’s device pathways rather than drug approval. That is why you will usually see the words “cleared” or “authorized,” not “approved.”

There are 2 main routes:

• 510(k) clearance. The maker shows the app is “substantially equivalent” to a device already on the market. This is the common route once a category exists.
• De Novo authorization. Used for new types of low-to-moderate risk devices with no existing equivalent. A De Novo grant usually creates a new classification that later products can follow.

One key classification is 21 CFR 882.5801, “computerized behavioral therapy device for psychiatric disorders.” The regulation describes a prescription-only, Class II device that provides a computerized version of condition-specific behavioral therapy, meant to supplement clinician-supervised outpatient care. Another classification, 21 CFR 882.5803, covers digital therapy devices for ADHD.

Class II means the FDA sets “special controls,” such as clinical performance testing, software validation and labeling requirements, that each product must meet.

Key takeaway: “FDA-cleared” means the agency reviewed evidence for a specific use in a specific group of patients. It does not mean the app works for everyone, or for conditions outside its label. Always check the cleared indication.

Examples of prescription digital therapeutics

A few well-known products show how the category has developed:

• reSET. In 2017 the FDA granted De Novo authorization to reSET, an app delivering behavioral therapy as an adjunct to outpatient treatment for substance use disorder. It is widely described as the first prescription digital therapeutic with claims to improve clinical outcomes.
• EndeavorRx. Authorized through De Novo in 2020, it is a video game-based treatment intended to improve attention function in children with ADHD, used as part of a broader treatment program.
• Rejoyn. Cleared in 2024 as an adjunct treatment for major depressive disorder in adults 22 and older who are taking antidepressant medication. It combines cognitive-emotional training exercises with short therapeutic lessons.

Other cleared products target insomnia, anxiety and chronic conditions. The FDA’s public device databases list cleared and authorized products if you want to check a specific app’s status.

The category has also had business setbacks. Pear Therapeutics, the company behind reSET, filed for Chapter 11 bankruptcy in April 2023, with insurer reimbursement widely cited as a key challenge. Its products were later taken over by other companies. The lesson for patients and clinicians: check that a product is still supported before you build a treatment plan around it.

Does insurance pay for prescription digital therapeutics?

This is where things get complicated. Coverage has historically been the biggest barrier.

Medicare. Starting in calendar year 2025, Medicare created 3 HCPCS codes, G0552, G0553 and G0554, for digital mental health treatment (DMHT) devices. G0552 covers supplying the device along with onboarding. G0553 and G0554 cover monthly treatment management time. To qualify, the device must be FDA-cleared under 510(k) or granted De Novo authorization under 21 CFR 882.5801, and used alongside ongoing behavioral health care under a treatment plan.

For calendar year 2026, CMS expanded those codes to also pay for ADHD digital therapy devices classified under 21 CFR 882.5803, again as an adjunct to clinician-supervised behavioral health treatment. CMS has not set a single national price for the device supply code; local Medicare contractors price it, while the 2 management codes have national pricing. Medicare also only pays for these devices according to the use indicated under their FDA classification.

Commercial insurance. Coverage varies by plan and product. Some insurers and employers cover specific PDTs; many do not. Some manufacturers offer patient assistance or cash-pay pricing.

Medicaid. Coverage depends on your state’s program. Some states have covered specific products, often through pilot programs or contracts.

Before starting, ask your clinician’s office to verify coverage, the same way you would check if a doctor is in network.

Do they actually work?

Each cleared product has clinical evidence behind its specific claim, but the strength of that evidence varies. Some products have randomized controlled trials; others have smaller studies. In some trials, the difference between the real app and a control or “sham” app has been modest, and independent experts have urged caution about early-stage research.

The broader research on whether mental health apps work is mixed, which is one reason prescription products emphasize clinical trials and clinician oversight. Practical questions to ask your clinician:

1. What did the clinical trial measure, and how big was the improvement?
2. Who was in the trial? Does that group match me?
3. What happens if I do not finish the program?
4. How will we track whether it is helping?

Privacy: is a prescription app covered by HIPAA?

Often, yes, but not always in the way you might assume. When a prescription digital therapeutic is part of care from a HIPAA-covered provider or plan, the provider’s records are protected. The app company’s own data handling depends on its role and contracts. Read the app’s privacy policy and ask what data is shared with your clinician, your insurer and the manufacturer. Our guide on whether your health app is covered by HIPAA explains the difference.

Where to start

If you think a prescription digital therapeutic might fit your care, here is a simple path:

1. Ask your clinician whether a cleared product exists for your condition and whether they prescribe it.
2. Check the FDA status and label. Confirm the indication, age range and whether it is meant as an add-on to other treatment.
3. Verify coverage with your insurer or Medicare before activating the app.
4. Read the privacy policy and understand who sees your usage data.
5. Set a check-in with your clinician, usually within the program’s treatment window, to review progress.
6. Know your alternatives. Many people do well with traditional therapy; see how online therapy works and what it costs.

If you are in crisis, an app is not the right tool. Call or text 988; our guide on how the 988 crisis line works explains what happens.

The bottom line

Prescription digital therapeutics are FDA-regulated software treatments that a clinician prescribes for a specific condition, usually as an add-on to standard care. They go through device pathways like 510(k) or De Novo, not drug approval. Coverage is improving, especially in Medicare for mental health and ADHD devices, but it remains inconsistent elsewhere. Ask about evidence, coverage and privacy before you start. For a wider look at where health software is heading, see AI in healthcare in 2026.

This is general information, not medical advice.

Sources

• eCFR / Cornell LII: 21 CFR 882.5801, Computerized behavioral therapy device for psychiatric disorders — prescription-only, Class II device definition
• CMS MLN Matters MM14315: CY 2026 Physician Fee Schedule final rule summary — expansion of G0552–G0554 to ADHD devices under 882.5803
• Otsuka and Click Therapeutics: FDA clearance of Rejoyn (press release) — Rejoyn indication and program design
• US FDA: Device Software Functions Including Mobile Medical Applications — how FDA regulates medical software