Before the COVID-19 pandemic, the Center for Healthcare Quality and Payment Reform found that 40% of all rural hospitals – almost 900 hospitals in total – were at a high or immediate risk of closure, with 25% or more of rural hospitals in 22 states at immediate risk of closure.
Fast forward to 2021. Although the U.S. Congress is working on bipartisan legislation to address the long-acknowledged – and now, with the pandemic, collectively experienced – physician shortage, access to in-person healthcare has reached an all-time low. On January 18, patients and physicians were locked out of Heights Hospital in Houston, Texas, because of the hospital’s past-due rent. A few days later, Santa Cruz Valley Regional Hospital, a hospital located in one of Arizona’s largest retirement communities, was forced to temporarily close its intensive care unit due to the hospital’s inability “to find, at any price, a pulmonologist” during the COVID-19 pandemic.
Dozens of news articles, press releases, and journal manuscripts tout plans for future innovation and claim that we’ve entered a new era of healthcare transformation, but for patients who no longer have a nearby hospital or ICU, the promise of connected care has moved further out of reach. Findings from a February 2021 study by the nonprofit RAND corporation suggest that, should the Centers for Medicare & Medicaid Services (CMS) stop reimbursement for audio-only telehealth, low-income patients will be disproportionately affected by and at risk of losing access to primary care and behavioral health. Many underserved patients lack access to the internet or video-enabled devices, and resources to support video telehealth at federally qualified health centers (FQHCs) are limited, creating new barriers to care for low-income patients. With millions of Americans having lost their jobs – and their employer-sponsored health insurance – during the pandemic, postponed preventative care has become commonplace.,
So, what should digital health innovators be doing? Innovating as fast as possible. Building technology that moves the conversation on healthcare and health equity beyond fighting for a $110 payment rate for phone calls (a.k.a. audio-only telehealth visits).
Most of the reimbursement and regulatory reform related to telehealth, virtual visits, and remote patient monitoring during the pandemic was implemented on a temporary basis, for the duration of the Public Health Emergency (PHE). Prior to the pandemic, telehealth reimbursement was cautiously implemented and restricted to rural areas and for specific diseases, with private payers and state insurance programs historically following reimbursement changes made by CMS. Whether the PHE remains in effect for 2021 and which reforms CMS and private insurers plan to keep is yet to be seen, though states are already looking to make permanent certain regulations regarding telehealth based on their unique experiences during the PHE. Although Medicaid continues to reimburse for telehealth visits for the duration of the PHE, some private payers have already rolled back coverage.
Where the role of telehealth lands in the long term – whether as a triaging tool to reduce ER visits or a follow-up tool hand-in-hand with remote patient monitoring – is still to be seen. Debate over how to reconcile telehealth services, from substitutes for in-person consults to supplemental virtual communication, with fee-for-service payment models will continue. As providers experiment with best practices to permanently integrate telehealth services in their care delivery systems, the results of multiple survey studies polling thousands of patients are clear: patient experience with telehealth during 2020 was positive overall.,,
Updates to the Anti-Kickback Statute now allow providers to offer wearable devices to patients for health purposes. Comments submitted on the rule included support from providers, and with provider buy-in on issuing wearables to patients, the integration of remote monitoring – and predictive analytics to prevent adverse events – will become more common. Five new current procedural terminology (CPT) codes for remote therapeutics monitoring and treatment management services (989X1, 989X2, 989X3, 989X4, 989X5) were approved and will take effect in January 2022.
In January, the FDA released its “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan.” Among its list of commitments, this first draft regulatory framework includes forthcoming guidance for change control plans for self-learning software during 2021. The plan also aims to develop “methods to evaluate and improve machine learning algorithms” and support “the development of good machine learning practices to evaluate and improve machine learning algorithms” in collaboration with universities and research institutes to address bias and algorithmic responsibility. To top off the list, the FDA is prioritizing a “patient-centered approach, including device transparency to users.” With software vulnerabilities present in 75% of health apps, expect medical device and software cybersecurity trends to influence the adoption of platforms and tools.
In February 2020, the FDA held a workshop for patients to share their perspectives on the “Evolving Role of Artificial Intelligence in Radiological Imaging” with product developers. As patients experimented with a range of digital health technologies during the pandemic and are tracking their health with the aid of apps, the potential to increase the diversity of patient perspectives and reduce dataset bias is more promising than ever. Now that patients are actively collaborating in health decision-making with their providers, longitudinal registries that track disease in real-time are possible. The FDA Center for Devices and Radiological Health (CDRH) is also seeking patient input across the digital health product lifecycle and engaging patients to provide patient preference information (PPI) in medical device decision-making and cybersecurity. Another outreach effort by FDA is the CDRH Patient Engagement Advisory Committee (PEAC), launched in 2020 to “help assure that the needs and experiences of patients are included as part of the FDA’s deliberations on complex issues involving the regulation of medical devices and their use by patients”. As new technologies blur the distinction between devices, software function, and level of risk, the FDA’s patient engagement strategy is key to developing guidance that can help innovators design the highest-quality digital health tools that reduce health disparities.
While the landscape of legislation and regulatory reform for healthcare – and access to critical utilities like energy and the internet – remains to be determined, one thing is certain: people need reliable access to healthcare. Whatever the “new normal” becomes, a healthier population will be more prepared to take advantage of opportunities to rebuild. “Necessity is the mother of invention,” and digital health in 2021 will surprise us as we adapt and overcome.
Learn more about the digital health ecosystem and some of the real world evidence behind the predictions in the sessions from Digital Medicine Conference 2020. They will be available on demand soon!
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NODE.Health is pleased to cross post this article giving the most up to date predictions for digital health specifically for 2021. NODE.Health encourages its readers to be diligent with understanding the real world evidence behind these predictions. As the adoption of digital health solutions increases, NODE.Health will keep its readers informed about the latest developments. Interested in learning more about the Network of Digital Evidence (NODE.Health)? Click here
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