To our knowledge, this is the first study to comprehensively estimate public and private sector contributions, via development of molecular diagnostic testing and treatments, in addressing COVID-19-related health system resource constraints in the USA. We found that the effect of public sector contributions and EUAs expanding and expediting the availability of COVID-19 commercial diagnostic tests and therapeutics likely had a significant effect on altering the trajectories of cases, mortality, and resource utilization. This finding is consistent despite uncertainty in private sector treatment effects, indicating that diagnostics alone may have a role in reducing health resource utilization, although the combination of both testing and treatments together produced a greater effect than either considered alone. While this model focuses on the cases and resource use from a US national perspective, regional differences in COVID-19 have been well documented. Since the availability of testing and treatment resources may vary regionally and may not align with the number of cases present in a particular geography, our model provides an optimistic scenario and highlights the importance of ensuring efficient and equitable distribution of treatments and diagnostics.
While this study focused on resource utilization, it is also important to consider the economic implications of resource reductions. Estimated COVID-19 healthcare costs per day to hospitals range from $2303 (non-ICU) to $3449 (ICU with ventilation) [28]. With hospitals facing substantial financial burden due to COVID-19, any diagnostic test or treatment which can reduce hospitalizations and LOS may provide significant cost savings. While estimating costs was beyond the scope of this study, it should be noted that the costs of a course of treatment for the only guideline-recommended COVID-19 treatments during this study period (remdesivir and dexamethasone) [29,30,31] are less than, or similar to, a single day in a hospital.
On the basis of our findings, public and private sector contributions have played an important role in addressing the pandemic; however, critical needs remain. Despite the increase in diagnostic testing capacity over time, laboratory backlogs have been observed [32]. As estimated in this study, time to test result is an important factor in reducing laboratory backlog and influences the infection curve and hospitalizations. Because of the urgency to increase testing capacity, other factors, including test sensitivity, have been less scrutinized. Our findings highlight that test sensitivity is an important consideration. In particular, the real-world clinical validity of available test options is largely unknown, and our results demonstrate that tests with lower sensitivity (i.e., increased false negative results) may lead to higher risk of viral transmission and increase healthcare resource utilization. Therefore, it is important to consider test system capacity, time to test result, and test sensitivity when evaluating the potential effectiveness of different testing strategies. Additionally, behavioral factors, such as patient compliance with self-isolation, are crucial for minimizing viral transmission. We found that the combination of poor patient self-isolation behaviors and lower test sensitivity can exacerbate the impact of false negatives on disease transmission and subsequent resource utilization. Therefore, when considering trade-offs between test sensitivity and time to test result, patient compliance with self-isolation behaviors is an important parameter to understand. Consequently, policies that support and enable people to self-isolate without penalties or risks (e.g., loss of employment, school, etc.) are important.
Effective treatments are equally important given the complementary effects of diagnostic testing on COVID-19 healthcare resource use and patient outcomes. Recent therapies issued EUA have involved both private sector contributions (e.g., remdesivir) and public funding (e.g., dexamethasone, convalescent plasma). We projected that the treatments (remdesivir, dexamethasone) have impacted mortality and non-ICU hospital resource use. Research and development (R&D) is occurring at a record pace, with over 300 therapies under investigation for COVID-19 [33]. These present potential opportunities to further reduce capacity constraints. This may be particularly important when considering individual treatment effects, since those that reduce mortality may increase hospital LOS because of the prolonged survival effect. This was the case in our study, where the effect of diagnostic testing alone led to a greater reduction in non-ICU beds than with testing and treatment. Therefore, a potentially optimal scenario may be a combination of novel treatments that balance the reduction in mortality and LOS outcomes. Production and distribution of any future vaccine at scale may be challenging; thus, development of novel treatments may have similar or even greater importance than vaccine development. However, unlike the rapid progress in diagnostic testing innovation, developing therapeutics has been more challenging, with many failed trials highlighting the difficulty of finding R&D success. Policies that continue to facilitate R&D are critical for the ability to develop innovative approaches to addressing the COVID-19 pandemic.
In addition to policies that facilitate R&D and allow recent innovations to be quickly available, those that enable patient access to these innovations are equally important. For example, the Coronavirus Aid, Relief and Economic Security (CARES) Act allows coverage of testing without cost-sharing, including those receiving testing out of network [34]. The significant impact diagnostic testing may have on multiple aspects of healthcare resource utilization, as observed in this study, highlights the importance of policies that facilitate patient access to testing resources. However, despite the enactment of these policies, there may still be subgroups of patients who are not covered by the CARES Act, such as the uninsured. Given rapid developments in the availability of testing technologies (e.g., antibody, antigen, multiplex molecular tests, etc.), the impact of testing on resource utilization, and current understanding that lower socioeconomic status patients—many who may be uninsured—are disproportionately affected by COVID-19 [35,36,37], policies that clarify coverage requirements and facilitate patient access to all COVID-19 testing technologies should be considered.
Unlike with testing, there is currently a lack of federal policies facilitating access to COVID-19 treatment via limiting cost-sharing. We found that treatment contributed a larger portion of the reduction in mortality relative to diagnostic testing, highlighting the importance of access to effective treatments. While many private payers have waived cost sharing for their members [38], some patients may still be vulnerable to high cost-sharing responsibilities, such as those with high deductible insurance plans (that have not waived cost sharing) or the uninsured. These patients may delay seeking care because of cost, resulting in additional resource utilization due to missed opportunities to leverage future/existing treatments at an earlier disease stage. Furthermore, delays or avoiding care may result in greater mortality [39, 40] and downstream productivity losses, accentuating the existing disparities in care. Future policies that ensure equitable access to hospital care and treatment should be considered.
Like all models, ours has limitations. First, the model assumes equal distribution of treatments and testing across the USA. In reality, healthcare resources in the USA are not equally distributed relative to need, so the impact of diagnostics and treatments may vary by individual health system. Thus, estimates of expected resource use relative to known availability of hospital/ICU beds and ventilators throughout the country should only be interpreted in aggregate across the country and are not necessarily reflective of the resource burden faced by individual health systems. Second, expanded testing scenarios assume that laboratory infrastructures are in place and the necessary consumables are widely available when this may not be the case. Lastly, the model assumes that treatments and testing became available instantaneously on a single date when in actuality the availability of new diagnostics and treatments was spread out over time. This may, for example, overestimate the impact of public sector contributions, as it is assumed that both public sector testing capacity and treatments (dexamethasone) were available at scale since the beginning of the pandemic.