PCORI Biweekly COVID-19 Scan: Adoption of IA in Revenue Cycle Management, Treating Fibromyalgia-Like Symptoms (May 26-June 8, 2022)
The Briefing provides an at-a-glance view of some important developments in the information universe surrounding COVID-19. The views presented here are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders.
Vaccines are back in the news. An Emergency Use Authorization (EUA) for the Novavax vaccine against COVID-19 is probable after a recent (June 7) FDA Vaccines and Related Biological Products Advisory Committee meeting. And an Advisory Committee meeting is upcoming (June 15) for Moderna’s EUA request for use of its vaccine in children 6 months through 5 years of age and Pfizer-BioNTech’s EUA request for children 6 months through 4 years of age.
The EUAs will position these vaccines to help lower COVID-19 infection rates. Novavax’s offering, a more traditional protein-based vaccine, is considered a viable alternative for people who choose not to receive an mRNA vaccine, while a vaccine for children younger than 5 years would protect a vulnerable population that currently has no vaccine options.
Many hoped that vaccination would offer not only protection from severe illness, but also reduce the risk of post-COVID conditions (or Post-Acute Sequelae of COVID-19 [PASC]). More research is needed, but a recent study of more than 13 million people found that vaccination reduced the likelihood of PASC by only about 15%. See Topics to Watch for a potential new treatment for post-COVID conditions.
ECRI Horizon Scanning has selected the topics below as those with potential for impact relative to COVID-19 in the United States within the next 12 months. All views presented are preliminary and based on readily available information at the time of writing.
Because these topics are rapidly developing, we cannot guarantee the accuracy of this information after the date listed on this publication. In addition, all views expressed in the commentary section are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders. Topics are listed in alphabetical order.
Increased Adoption of Intelligent Automation to Aid in Health Care Revenue Cycle Management in Response to the COVID-19 Pandemic
At a Glance
- Intelligent automation (IA), an automation technology that combines artificial intelligence, business process management, and robotic process automation, is being increasingly adopted by the health care industry to aid in revenue cycle management.
- Health care revenue cycle management presents complex issues, such as decentralized processes, inefficient systems, human error, and staffing shortages in revenue cycle management, which together result in losses of billions of dollars annually.
- Utilizing IA in revenue cycle management might help streamline administrative operations to decrease administrative costs and increase revenue, as well as mitigate staffing shortages.
- Health care technology companies are offering platforms designed to perform manual and redundant tasks such as medical coding, billing, revenue collections, and managing claim denials.
The health care industry is adopting intelligent automation (IA) in revenue cycle management. IA is an automation technology that combines artificial intelligence (machine learning), business process management, and robotic process automation. Its potential benefits are streamlining and simplifying workflows and handling complex tasks and use cases.
A series of COVID-19 surges increased challenges in health care work environments, spurred burnout among health care staff, and resulted in many staff leaving, or planning to leave, the industry in the next few years . Additionally, a 2021 health care labor market projection highlighted that the health care industry would face critical staff shortages within the next five years. The reduced workforce will prolong the difficulty for clinics to manage their revenue cycles efficiently.
Traditional insurance claims management processes cost US health care systems billions of dollars annually because of insurance claim denials and claim errors. Finding a solution has been impeded by the complexity of the issue. The processes are decentralized, prone to human error, and fraught with inefficiencies. Many organizations are unable to dedicate the necessary labor for performing claim checking and resubmission, and revenue cycle staffing shortages have recently increased.
Using IA in health care revenue cycle management might streamline tasks related to medical coding, billing, and claim management and reduce the required staff for these tasks associated labor costs. It can automate workflows by adding specific administrative terminology, such as ICD-10 (International Classification of Diseases, 10th Version) or HEDIS (Healthcare Effectiveness Data and Information Set) codes, into electronic medical records for regulatory compliance and reimbursement.
IA is being increasingly utilized in health care revenue cycle management. Examples of health care technology companies offering such automation platforms are Akasa, Inc (South San Francisco, California) and Meduit, Inc (Charlotte, North Carolina).
We were unable to find cost information for the use of IA in revenue cycle management. According to McKinsey & Co, payers might save an estimated 30% of operating expenses by employing robotic and automation solutions to claims processing. According to Automation Anywhere, a survey by ETR found robotic process automation provided a customer return on investment of 250% across industries.
IA requires a high financial investment initially, but it could improve the operational efficiency of revenue cycle management processes at clinics and hospitals and result in cost and labor savings.
Early feedback from ECRI internal stakeholders suggested IA might help reduce health care administrative burden by automating medical coding and billing tasks, which can be time-consuming and labor-intensive. If this technology is adopted as intended, it might reduce human error and reduce burnout associated with fixing errors, improving accuracy and efficiency. Automation might alleviate burden on health systems due to current staffing shortages.
Reducing the time spent on administrative tasks related to appeals for claims denials and prior authorization requests could allow clinicians to spend more time providing direct patient care and improve patient engagement and satisfaction. Stakeholders thought that IA technology could also reduce health care costs because of better resource allocation and faster claims management. Stakeholders noted it might take time to integrate this technology into practice.
- Categories: Systems and management
- Areas of potential impact: Population health, health care delivery and process, health care costs, and health care disparities
Sublingual Cyclobenzaprine (TNX-102 SL) to Treat Fibromyalgia-Like Symptoms in Post-Acute Sequelae of COVID-19
At a Glance
- Sublingual cyclobenzaprine is under investigation as TNX-102 SL to treat patients with fibromyalgia-like symptoms in Post-Acute Sequelae of COVID-19 (PASC). Over 40% of patients with PASC have been found to have fibromyalgia-like symptoms.
- FDA has not authorized or approved any treatments for PASC; thus, an unmet medical need exists for effective PASC treatments.
- TNX-102 SL has demonstrated efficacy in clinical trials for treating fibromyalgia, a chronic pain syndrome with common accompanying symptoms such as fatigue, sleep disturbance, and cognitive dysfunction.
- The developer of TNX-102 SL, Tonix Pharmaceuticals, anticipates beginning a pivotal phase 2 trial to assess its drug as a treatment for fibromyalgia-like symptoms in PASC in the second half of 2022.
Sublingual cyclobenzaprine will be studied as TNX-102 SL (Tonix Pharmaceuticals, Chatham, New Jersey) in an upcoming phase 2 trial to treat patients who have PASC, or long COVID, with fibromyalgia-like symptoms.
An estimated 30% of people treated for COVID-19 develop PASC. PASC symptoms are variable and may include (in alphabetic order) anxiety, cognitive impairment, depression, fatigue, fever, gastrointestinal issues, pain, shortness of breath, and sleep disorders. Incomplete understanding of the underlying causes of PASC and a lack of treatments authorized or approved by the FDA highlight the unmet medical need for treating patients with PASC.
Fibromyalgia is a syndrome characterized primarily by widespread, persistent, and potentially debilitating pain, thought to occur as a result of persistent physical or psychological stress in predisposed individuals. A recent study of 52,000 patients with post-COVID-19 symptoms noted similarities between fibromyalgia symptoms and the neurological manifestations of PASC and found that more than 40% of patients with PASC had fibromyalgia-like symptoms of multisite pain, fatigue, sleep disturbance, cognitive dysfunction, and psychological distress. At this time, fibromyalgia has few treatments including pregabalin (Lyrica), duloxetine (Cymbalta), and milnacipran (Savella).
Cyclobenzaprine is a centrally acting skeletal muscle relaxant, structurally related to tricyclic antidepressants. It is being developed for fibromyalgia as TNX-102 SL and has demonstrated efficacy in reducing daily pain and improving symptoms such as sleep and fatigue in patients with fibromyalgia. Based on these efficacy data and observed symptom overlap with PASC, Tonix Pharmaceuticals anticipates starting a phase 2 trial in the second half of 2022 evaluating the safety and efficacy of TNX-102 SL for treating fibromyalgia-like symptoms in patients with PASC.
We were unable to find information regarding the potential cost for TNX-102 SL for this indication.
TNX-102 SL might help address an unmet need for effective PASC treatments by treating patients who have fibromyalgia-like symptoms.
Early feedback from ECRI internal stakeholders suggested that although more data are needed to determine its efficacy, TNX-102 SL has potential to disrupt PASC standard of care and improve patient outcomes. A significant unmet medical need is highlighted by an incomplete understanding of PASC and lack of effective treatments for this condition. However, TNX-102 SL might carry risks that should be studied and monitored closely. Cyclobenzaprine is not recommended for prolonged use and has serious interactions with some other drugs. It might have less risk for abuse and dependency than do opioids for treating symptoms of pain, however.
Stakeholders thought that a current lack of standardization in diagnosing and classifying eligible patients might raise challenges and limit TNX-102’s clinical uptake. Even if it is approved to treat PASC, providers and patients could face barriers to accessibility and coverage from insurers, based on the level and quality of clinical trial evidence available. Clinicians might prefer prescribing treatments that are FDA-approved for fibromyalgia instead.
- Categories: Treatment
- Areas of potential impact: Patient outcomes, health care disparities, health care costs
Horizon scanning is a systematic process that serves as an early warning system to inform decision makers about possible future opportunities and threats. Health care horizon scanning identifies technologies, innovations, and trends with potential to cause future shifts or disruptions—positive or negative—in areas such as access to care, care delivery processes, care setting, costs of care, current treatment models or paradigms, health disparities, health care infrastructure, public health, and patient health outcomes.
The PCORI Health Care Horizon Scanning System (HCHSS) conducts horizon scanning to better inform its patient-centered outcomes research investments. Initially, PCORI defined the HCHSS project scope to focus on interventions with high potential for disruption in the United States in 5 priority areas: Alzheimer’s disease and other dementias, cancer, cardiovascular diseases, mental and behavioral health conditions, and rare diseases. In addition, the system captures high-level disruptive trends across all clinical areas, which may lead PCORI to expand the project scope to include other priority areas in the future.
In early 2020, the COVID-19 pandemic created a fast-moving, widespread public health crisis. In May 2020, PCORI expanded its HCHSS to elucidate the landscape of potentially impactful applications for COVID-19. The HCHSS COVID-19 supplement scans for, identifies, monitors, and reports on emerging and available COVID-19-related treatments, diagnostics, preventive measures, management strategies, and systems changes with potential for high impact to patient outcomes—for individuals and populations—in the United States in the next 12 months.
The HCHSS COVID-19 supplement produces 3 main outputs:
- Biweekly COVID-19 Scans (eg, this document) provide ECRI Horizon Scanning with a vehicle to inform PCORI and the public in a timely manner of important topics of interest identified during ongoing scanning and topic identification or through the ECRI stakeholder survey process.
- Status Reports (quarterly) briefly list and describe all COVID-19-related topics identified, monitored, and recently archived.
- High Impact Reports (every 4 months) highlight those topics that ECRI internal stakeholders (eg, physicians, nurses, allied health professionals, public health professionals, first responders, health systems experts, clinical engineers, researchers, business and finance professionals, and information technology professionals) have identified as having potential for high impact relative to COVID-19 in the United States.
Commentary in this COVID-19 Scan reflects preliminary views of ECRI Horizon Scanning and internal ECRI stakeholders.
The information contained in this document has not been vetted by other stakeholders.
We welcome your comments on this Scan. Send them by email to [email protected].
Posted: June 16, 2022
What's Happening at PCORI?
The Patient-Centered Outcomes Research Institute sends weekly emails about opportunities to apply for funding, newly funded research studies and engagement projects, results of our funded research, webinars, and other new information posted on our site.