You are sitting in the exam room with your doctor. She tells you that there’s a low-risk, no side effect option for treating your insomnia. She’d like you to try this before considering medications. You leave with a prescription. But it can’t be filled at the corner pharmacy. You need to submit it to your insurance, wait for them to process it, and send you an activation code. 

Sometime in the next one to six weeks, you are ready to get started with an app that your insurance company paid 220€ for you to access for 8 weeks. You configure multi-factor authentication, complete the onboarding process, take a break to grab a snack from the fridge, and… you are signed out. The app was inactive for a few minutes while you were prepping a snack, so now you need to log back in. That night, instead of falling asleep promptly with your new app, you doom-scroll search results on why the user experience for Digital Therapeutics is so horrendous. 

This article will explore the Reimbursement and Use dynamics of Digital Therapeutics, and what we can do to improve health outcomes and patient experience into the future.

Reimbursement

There is significant interest from Digital Health companies in being able to directly bill health insurance for access to their apps. In some countries, like Germany (DiGAs) and France (PECAN), there is already a pathway to direct reimbursement from insurance. 

A few major challenges to this include:

  1. The bureaucratic barriers to reimbursement produce a lot of overhead for Digital Health companies. The only way to make this “worth it” is to charge much more than would be typical for access to a low risk, non-invasive software application. 
  2. The process requires a prescription by a healthcare provider (typically physician or therapist), and these providers are not in the habit of writing prescriptions for or advocating for the safety and efficacy of low risk, non-invasive software applications. 
  3. Actually receiving access to the product once a prescription is written takes time, waiting periods, and low tech processes such as mailing access codes to patients. 

All of this added process and complexity consumes time, effort, energy, and cash from healthcare systems. Systems that are taxed by the increasing costs of providing care for aging people who have growing rates of chronic and preventable health conditions. 

Another concern about reimbursement is whether or not patients are actually using these Digital Therapeutics regularly to achieve substantial benefit. Very few Digital Health companies openly share their usage, completion, and symptom response data. If Insurance is paying for access, but people are not using the products effectively and achieving improved health outcomes, then this is an unnecessary drain on the healthcare system. 

Friction also comes from healthcare providers who are expected to prescribe these Digital Therapeutics. They are well trained, capable providers who know the patient well, spend time counseling and coordinating care, and ultimately making recommendations for a treatment plan. When they counsel someone on the use of a new Continuous Glucose Monitor, or provide Cognitive Behavioral Therapy skill training to a patient, they are reimbursed for this. If they prescribe a DiGA in Germany, the Digital Health company receives hundreds of Euros per patient, and the provider receives little to no compensation. What does this communicate to the prescribing physician or therapist? 

The beauty of software is that it scales effectively without scaling costs. People can binge watch as many movies and TV shows as they would like on Netflix for one low monthly payment. Many prominent products and services scale to millions of users without having to charge a cent. This is because cloud services have lowered the barrier to providing software applications at scale to a level where a single person can stand up a product to serve millions. 

Healthcare needs software to be scaling solutions that make a lasting impact while driving costs as low as reasonable. This means very easy processes, simple payment schemes, and aligned incentives between patients, healthcare providers, insurance, and Digital Health companies.  

Some changes that make sense from my perspective: 

  1. Access to software-only Digital Therapeutics should be free and immediate to patients. 
  2. Reimbursement should primarily be to the provider that is overseeing the care of the patient. 
  3. Payment to the Digital Health company should be results-based, and variable to the level of value that is gained by the patient, provider, and payor. 

Why free and immediate? Because it’s not hard to make this a reality. The software solutions we have in Digital Therapeutics are based on decades of research on what works. Governments and universities have been funding research for the public good, and billions have already been spent to create the current state of the science. Software is a research-delivery platform. An effective way to disseminate these learnings to as many patients as possible. I think we need to take a more practical view of the apps we create, and acknowledge that they are an accessible publishing platform, and not multi-billion dollar advancements in healthcare innovation at launch. 

Why should primary reimbursement be to the healthcare provider? Digital Therapeutics are not hardware medical devices or prescription pharmaceuticals. They do not require the same level of R&D, tooling, or distribution logistics. They also are not consumables - one person using an app doesn’t use it up or mean that another person is unable to use it. They should not be reimbursed as if they are Medical Devices or Pharmaceuticals. They should be reimbursed similarly to the way that other skill trainings and resources for clinicians are reimbursed - through sales of toolkits, training programs, and other resources that make care delivery easier and better. This could be through select contracts with insurance, through sales to clinics and providers, or low cost resources direct to patients and eligible for reimbursement. This is research dissemination, not drug delivery. The clinician should be reimbursed for doing the work, and payments to the Digital Health company should come from success cases, providing excellent value to the clinician or insurance company, or through enabling improved billing, customization, etc for the clinical practice and health system as a whole. 

Use of Digital Therapeutics in Clinical Practice

If we solve all of the issues surrounding Reimbursement for Digital Therapeutics, we have another major question: How exactly should they be used in practice? 

Most of the newer class of Digital Therapeutics, which focus on creating an intervention for a patient to follow independently in an app, have extremely limited integration into clinical care. This is in sharp contrast to their predecessors, which are Remote Patient Monitoring, Remote Therapeutic Monitoring, Decision Support, and Patient Portal offerings. This new class of Digital Therapeutics are like workbooks or self-help resources a patient can use, and could be recommended by a healthcare provider. 

There is a huge lost opportunity with this current dynamic. I imagine the level of benefit patients and their healthcare providers will experience when Digital Therapeutics are integrated into the care dynamic, providing insight back to the primary treatment plan, and facilitating  bilateral communication between provider and patient. This future Digital Therapeutic is what I envision as the ideal digital companion to clinical care. A software platform that a patient can use regardless of specific diagnosis, indication, or current treatment needs.

Care should remain patient-centric and provider enabled. This means that incorporating Digital Therapeutics into a treatment plan is not a handoff where a provider writes a prescription or makes a referral, and then the patient spins off and has a separate relationship with a Digital Health company. Providers should have Digital Therapeutics as a tool in their toolkit that can be offered to patients as a benefit, resource, and additional avenue for communication. 

The future is in an integrated experience where physicians, therapists, and other healthcare providers can offer all of their patients - not just some - a platform that is integrated with their electronic health record (EHR) and provides a suite of Digital Therapeutics that can be used at the discretion of the patient and provider. Remote Therapeutic Monitoring and DTx in a single platform. Billing and coding back to the EHR so that the provider is reimbursed for the efforts to support comprehensive and coordinated care.