--- title: Using real-world data to justify coverage for digital health solutions description: Digital health has left a lasting impact post-pandemic and real-world data can help providers differentiate themselves and ensure long-term success image: https://blog.healthverity.com/hubfs/Demonstrating-the-Value-of-Digital-Health-Post-Pandemic.jpg --- Announcing HealthVerity Precision Event Alerts, a next-generation physician alerting solution. 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Symphony Solutions Health technology and business intelligence solutions Integrated Dataverse and Source Solutions Brand strategy and sales HealthRankings Market access Patient Journey Medicines affordability Symphony Products PayerSource® PrescriberSource® PatientSource® PatientSourceCompleteTM PatientSourceDUOTM Symphony FLEXTM CustomerSource® DiagnosticSource® NonRetailSource® Symphony Technology Symphony HealthCloud Synoma Data Integration Vantage Applications Metys ###### Life Sciences Technology solutions from development through commercialization ###### Channel Partners HealthVerity enables partners to unlock unprecedented value and insights for clients ###### Government Comprehensive and compliant solutions to manage the nation’s care ###### Data Ecosystem Partners Join the nation’s largest data partner ecosystem ###### Insurance Insurance-grade solutions that excel in managing risk and rebates ###### HealthVerity Blog Insights and updates from industry experts ###### Publications Peer-reviewed research and discoveries ###### News & Events Stay informed about our latest announcements and happenings ###### The IPGE Approach Fundamentals that power everything that we do and every solution we offer ###### Resource Library Explore guides, webinars, and tools to enhance your understanding ###### Zombie Data Explained Learn how data quality drives better research outcomes [Trends & Insights](https://blog.healthverity.com/tag/trends-insights), [Solutions & Best Practices](https://blog.healthverity.com/tag/solutions-best-practices) # Using real-world data to justify coverage for digital health solutions [By - HealthVerity,](https://blog.healthverity.com/author/healthverity) February 23, 2023 ![](https://blog.healthverity.com/hubfs/Demonstrating-the-Value-of-Digital-Health-Post-Pandemic.jpg) Today’s most innovative companies are leveraging digital health data solutions to deliver real-world evidence that supports clinical outcomes, cost-effectiveness, and long-term reimbursement strategies. However, in order to separate themselves from a crowded field and ensure their long-term success, digital health providers will have to demonstrate their value to not only their consumers, but also other key constituents, including employers, insurance companies and government agencies.   # Will payers cover your digital health product? The real-world evidence you'll need: For digital health products to remain low cost or free to consumers, the cost is often covered or subsidized by employers, insurance companies, Medicare or Medicaid. Whether it’s a telehealth visit, a virtual chronic care management program or a digital therapeutic, a few factors influence their willingness to pay, including: ### Limited Clinical Evidence Traditional drug therapies used in treating conditions go through a rigorous FDA approval process to prove their safety and efficacy that requires at least two clinical trials. This type of clinical evidence does not always readily exist for digital health products. Even digital therapeutics that are regulated by the FDA go through a different approval process that does not require clinical trials, but rather a demonstration that it is safe and effective when compared to other devices or reasonable assurances of its safety and efficacy, depending on the approval pathway.1,2 Real-world data for digital health reimbursement is increasingly becoming a requirement for coverage decisions. ### Cost Concerns When it comes to costs, insurance, and employer coverage digital health is no exception. A recent survey by the leading benefits advisory company WTW, found that 9 out of 10 employers are planning to change health and wellbeing vendors in the next two years as they take a closer look at the value and cost savings that vendors can provide.3 Prior to the pandemic, Medicare did not cover the cost of telehealth visits. Now that things are returning to normal, Congress is studying the cost effectiveness and value of telehealth visits and trying to determine if they should be reimbursed at the same rate as an in-person doctor's visit.4 Concerns were also voiced that the ease of telehealth could lead to more visits and, thus, more costs, as well as the potential for fraud.  Additionally, an Institute for Clinical and Economic Review (ICER) report on digital therapeutics used to treat opioid use disorder found that a particular product, with a price tag of $1,200, was only cost effective if the patient remained abstinent for five years or more.5 These examples show how insurance companies and governing bodies are questioning the costs of digital health. ### Lack of Guidance As a relatively new and evolving therapy area, there is a lack of guidance on who and how to cover some digital health products and services. For example, while some digital therapeutics require a prescription, they often offer cognitive behavior therapy, which is typically covered under the medical benefit. Additionally, digital therapeutics do not have national drug code numbers, which are traditionally used for billing and reimbursement of prescriptions. All of this makes it easier for insurance companies to simply deny coverage.     # Earning consumer trust in digital health Consumer acceptance brings a different set of challenges. Some people do not trust the technology. They could fear privacy issues, believe face-to-face interactions are better, or they simply might not have the skillset to understand and use the products.  Another issue is the sheer volume of options available. According to an article in *Chief Healthcare Executive* magazine, there were 325,000 health and fitness apps on the market in 2018 and probably even more today.6 Additionally, many behavioral health oriented digital products focus on the same chronic conditions, such as diabetes, cardiovascular disease and musculoskeletal issues. This means that providers need to find a way to differentiate themselves and prove their worth. # The proof is in the real-world data RWD plays a critical role in digital health ROI assessments and helps decision-makers evaluate how digital therapeutics perform outside controlled trials. Leading digital health companies use RWD to differentiate their product, meet payer requirements, and demonstrate value to providers and regulators alike. To overcome these hurdles, you need to be able to provide clinical evidence that your digital health product improves patient outcomes equally or better than conventional alternatives, as well as the cost effectiveness compared to other therapies or not seeking treatment.  Real-world data (RWD) from sources such as medical and pharmacy claims, electronic health records, hospital chargemaster data, and lab results can provide a longitudinal view of the patient’s healthcare journey: conditions they’ve been diagnosed with, treatments they’ve received, healthcare visits they’ve had and other valuable information. This data can be analyzed to demonstrate improved patient outcomes and a positive return on investment. By establishing a control group, comparator analyses can be generated to determine cost effectiveness compared to alternative treatments and provide real-world clinical evidence on the performance of your product versus other treatments or care delivery models.  However, there are also challenges in accessing RWD. A variety of data is needed from the right sources in order to conduct these analyses, giving a view into both the patient journey and the cost effectiveness. These various data sources need to be procured and the patients de-identified to meet privacy regulations. The RWD also needs to be interoperable with your primary data that includes your existing patients and it all needs to be normalized into a standard format to apply the appropriate analytics. This can take a lot of time and resources. # HealthVerity offers a turnkey digital health solution De-Identify and Match Patients - With [HealthVerity Identity Manager](https://healthverity.com/solutions/healthverity-census/), we use advanced patient identity resolution techniques to de-identify and compliantly match patient records persistently over time and across data sources, including your patient data. This allows you to supplement your data or seamlessly select a control group. Find the Data You Need - [HealthVerity Marketplace](https://healthverity.com/solutions/healthverity-marketplace/), the nation’s largest interoperable, HIPAA-compliant healthcare and consumer data ecosystem, with over 75 data sources representing more than 330 million patients, allows you to easily discover and license only the data you need. Conduct Analyses Using Data Fit for Your Purpose  - All of HealthVerity data is HIPAA compliant and research ready when you receive it. Additionally, we normalize the data so that it fits seamlessly into your workflows. Combine Data and Do a Custom HIPAA Certificate - If you choose to combine different datasets (e.g., your patient data with HealthVerity real-world data), we can complete the custom HIPAA certification process so you only focus on bringing your study to life. [Learn more](https://blog.healthverity.com/matching-accuracy-metrics) about how HealthVerity de-identifies data to HIPAA compliance. HealthVerity delivers HIPAA-compliant digital health analytics with research-ready real-world data to help digital health innovators succeed in today’s competitive and evidence-driven environment. [![See how Verified Data can transform your real-world evidence strategy](https://no-cache.hubspot.com/cta/default/5412465/interactive-186304843896.png)](https://blog.healthverity.com/hs/cta/wi/redirect?encryptedPayload=AVxigLLptb2Szrbj7SmOEvVCA2QX6IzqV1ge2ri7je3n2iZiS%2FA8cUkZj%2FhlcT5U4OTWL5exFswrFJ3EMYFwpuvBeJGQN8yzKDiW2ixjDVnhL9cfuEw3LKfWLCYizi5IXYnjE8%2BD5P1RLgCoIIAsigfDWwN9wuUgWbaEhDmsoE4Oeu%2FbTE1AIuCj5wnvOsmUcZM%3D&webInteractiveContentId=186304843896&portalId=5412465) # References 1. U.S. Food & Drug Administration (FDA). Premarket Notification 510(k). [https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k) 2. FDA. De Novo Classification Request. [https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request) 3. WTW (2023). 9 in 10 employers plan to change health and wellbeing vendors in next two years, WTW survey finds. [https://www.wtwco.com/en-US/news/2023/02/9-in-10-employers-plan-to-change-health-and-wellbeing-vendors-in-next-two-years-wtw-survey-finds](https://www.wtwco.com/en-US/news/2023/02/9-in-10-employers-plan-to-change-health-and-wellbeing-vendors-in-next-two-years-wtw-survey-finds) 4. Tribble, S. J. (2023). It’s ‘Telehealth vs. No Care’: Doctors Say Congress Risks Leaving Patients Vulnerable. Kaiser Health News. January 31, 2023. [https://khn.org/news/article/its-telehealth-vs-no-care-doctors-say-congress-risks-leaving-patients-vulnerable/](https://khn.org/news/article/its-telehealth-vs-no-care-doctors-say-congress-risks-leaving-patients-vulnerable/) 5. Institute for Clinical and Economic Review. Digital Health Technologies as an Adjunct to Medication Assisted Therapy for Opioid Use Disorder. November 6, 2020. [https://icer.org/wp-content/uploads/2020/08/ICER\_Digital\_Therapeutics\_for\_OUD\_Evidence\_Report.pdf](https://icer.org/wp-content/uploads/2020/08/ICER_Digital_Therapeutics_for_OUD_Evidence_Report.pdf.) 6. Murtha, Jack (2018). Why the Future of Digital Health Must Be Simple. Chief Healthcare Executive magazine. October 18, 2018. [https://www.chiefhealthcareexecutive.com/view/why-the-future-of-digital-health-must-be-simple](https://www.chiefhealthcareexecutive.com/view/why-the-future-of-digital-health-must-be-simple) ###### Category - [Solutions & Best Practices](https://blog.healthverity.com/tag/solutions-best-practices) - [Trends & Insights](https://blog.healthverity.com/tag/trends-insights) - [HEOR](https://blog.healthverity.com/tag/heor) - [Thought Leadership](https://blog.healthverity.com/tag/thought-leadership) - [Marketplace](https://blog.healthverity.com/tag/marketplace) - [taXonomy](https://blog.healthverity.com/tag/taxonomy) - [Industry Updates](https://blog.healthverity.com/tag/industry-updates) - [Case Studies](https://blog.healthverity.com/tag/case-studies) - [Commercial Pharmaceutical](https://blog.healthverity.com/tag/commercial-pharmaceutical) - [Government](https://blog.healthverity.com/tag/government) - [AI](https://blog.healthverity.com/tag/ai) - [eXOs](https://blog.healthverity.com/tag/exos) - [Audiences](https://blog.healthverity.com/tag/audiences) - [taXonomy Pathways](https://blog.healthverity.com/tag/taxonomy-pathways) - [Notes](https://blog.healthverity.com/tag/notes) - [Rare Diseases](https://blog.healthverity.com/tag/rare-diseases) ###### Popular Post - [The GLP-1 trend: What the real-world data reveals](https://blog.healthverity.com/the-glp-1-surge-what-the-real-world-data-reveals) - [GLP-1 trends 2025: real-world data, patient outcomes & future therapies](https://blog.healthverity.com/glp-1-trends-2025-real-world-data-patient-outcomes-future-therapies) - [Open claims vs. closed payer claims: What’s the difference?](https://blog.healthverity.com/open-claims-vs-closed-payer-claims) - [What is Privacy Preserving Record Linkage (PPRL)?](https://blog.healthverity.com/what-is-privacy-preserving-record-linkage) - [GLP‑1 real‑world data for obesity: A new standard for metabolic care](https://blog.healthverity.com/glp-1-real-world-data-for-obesity-a-new-standard-for-metabolic-care) ###### Subscribe ### Similar Blogs [![Unlock open and closed claims data with taXOnomy: Claim better outreach](https://blog.healthverity.com/hs-fs/hubfs/claim-better-outreach-blog.png?width=352&name=claim-better-outreach-blog.png)](https://blog.healthverity.com/claim-better-outreach) #### [Unlock open and closed claims data with taXOnomy: Claim better outreach](https://blog.healthverity.com/claim-better-outreach) By [HealthVerity](https://blog.healthverity.com/author/healthverity) 25 September 2024 In the evolving world of real-world data (RWD), pharmaceutical companies are increasingly focused... 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