The diagnostic industry is benefiting from new innovation and data collection opportunities provided by telemetry, wearable diagnostics, and remote patient monitoring devices. These devices are collecting more patient diagnostic and monitoring information than ever before. They also help to save time in the diagnosis and treatment process, reduce healthcare costs, and help physicians monitor patients to ensure they are achieving the expected outcomes of their treatment or therapy. However, for new healthcare technologies to be successfully adopted by physicians and patients, companies need to gain acceptance with healthcare insurance payors to cover these new devices. This is not a simple process. Payors are literally inundated with requests to cover a wide variety of new diagnostics and technologies and can struggle to verify the therapeutic value of new devices. In this environment, a financially-based technological foundation can spell the difference between success and failure for a device.
Kyle Fetter, Executive VP & GM of Diagnostic Services, XIFIN
Medical device claims are adjudicated based on the eligibility criteria and restrictions of each payor’s coverage policies. However, without a body of compelling evidence in the form of peer-reviewed publications and/or FDA clearance or approval, new healthcare technologies, such as monitoring devices, can be considered unproven or not a medical necessity thus resulting in claims denials. If claims are not successfully appealed, the financial responsibility of non-reimbursed diagnostic and monitoring devices is either absorbed by the device company or transferred to the patient. In the near term, the path to reimbursement is dependent upon access to the clinical information needed to establish medical necessity to support appeals. For long-term success, these companies need to also consider the accumulation of real-world data (RWD) and the development of real-world evidence (RWE) as a path to establish payor coverage.
Healthcare informatics systems that curate laboratory and clinical data can be used to improve the claims appeals process as well as develop RWE in support of clinical utility for long term coverage. Informatics solutions can automate the extraction of key clinical data including CPT, ICD and other codes as well as treatment notes and patient outcomes – all of which are required by payors to establish medical necessity and required for claims adjudication. The same standardized approach to data collection can be used to establish a data lake that can be analyzed according to disease category or other relevant criteria and the findings published as evidence in support of clinical utility.
In addition to overturning denials and establishing coverage, RWD can also be used for determining and monitoring quality of care, FDA regulatory submissions, disease insights research, as well as monitoring of drug treatment safety and effectiveness. RWD and RWE are more representative of actual population demographics, take into account patient adherence to therapeutic regimens, and can be used for comparative effectiveness studies. Compared to traditional clinical trials designs, which are often used to establish clinical utility, the use of RWD is more cost effective and enables the collection of searchable data (outcomes) that might not otherwise be captured or accessible.
In summary, the curation of diagnostic and clinical data into a unified healthcare informatics platform has both near- and long-term financial advantages to companies developing remote patient monitoring and other diagnostic medical devices. It will take time for these companies to gather sufficient patient cases to develop high quality, compelling evidence stories for peer-reviewed publication, FDA and/or payor submissions. In the meantime, this data is being generated. Why not use it to improve the success of appeals, coverage, and reimbursement?
To learn more, read these blog posts: