Regulatory Approach to Point-of-Care/At-Home Testing in the United States.

The Clinical Laboratory Improvement Amendments (CLIA) classifications were activated in the 1990s in partnership with the Centers for Medicare and Medicaid Services and Food and Drug Administration and included waived, moderate, and high complexity testing. The waived section of CLIA certificates allows laboratories to perform testing of analytes and methods of samples by the Food and Drug Administration. During the COVID-19 pandemic, many molecular or antigen laboratory testing methods for COVID-19 virus were quickly approved by emergency use authorization. Waived testing is now done in highly complex, moderately complex, and waived testing laboratories, and some at-home testing.

Healthcare Workers Weather Respiratory Onslaught

The article offers information on how healthcare workers are facing a rare convergence of a pandemic virus and unusually high levels of seasonal flu and respiratory syncytial virus (RSV). Topics include information on increase in patients with respiratory virus;comments of Ryan Stanton, MD, and a member of Central Emergency Physicians in Lexington, Kentucky;and how physicians are facing lot of strain.

Model-based evaluation of policy impacts and the continued COVID-19 risk at long term care facilities.

The COVID-19 pandemic severely impacted long-term care facilities resulting in the death of approximately 8% of residents nationwide as of March 2021. As COVID-19 case rates declined and state and county restrictions were lifted in spring 2021, facility managers, local and state health agencies were challenged with defining their own policies moving forward to appropriately mitigate disease transmission. The continued emergence of variants of concern and variable vaccine uptake across facilities highlighted the need for a readily available tool that can be employed at the facility-level to determine best practices for mitigation and ensure resident and staff safety. To assist leadership in determining the impact of various infection surveillance and response strategies, we developed an agent-based model and an online dashboard interface that simulates COVID-19 infection within congregate care settings under various mitigation measures. This dashboard quantifies the continued risk for COVID-19 infections within a facility given a designated testing schedule and vaccine requirements. Key findings were that choice of COVID-19 diagnostic (ex. nasal swab qRT-PCR vs rapid antigen) and testing cadence has less impact on attack rate and staff workdays missed than does vaccination rates among staff and residents. Specifically, low vaccine uptake among staff at long-term care facilities puts staff and residents at risk of ongoing COVID-19 outbreaks. Here we present our model and dashboard as an exemplar of a tool for state public health officials and facility directors to gain insights from an infectious disease model that can directly inform policy decisions in the midst of a pandemic.

Fourth Wave of Opioid (Illicit Drug) Overdose Deaths and Diminishing Access to Prescription Opioids and Interventional Techniques: Cause and Effect

BACKGROUND: In the midst of the COVID-19 pandemic, data has shown that age-adjusted overdose death rates involving synthetic opioids, psychostimulants, cocaine, and heroin have been increasing, including prescription opioid deaths, which were declining, but, recently, reversing the trends. Contrary to widely held perceptions, the problem of misuse, abuse, and diversion of prescription opioids has been the least of all the factors in recent years. Consequently, it is important to properly distinguish between the role of illicit and prescription opioids in the current opioid crisis. Multiple efforts have been based on consensus on administrative policies for certain harm reduction strategies for individuals actively using illicit drugs and reducing opioid prescriptions leading to curbing of medically needed opioids, which have been ineffective. While there is no denial that prescription opioids can be misused, abused, and diverted, the policies have oversimplified the issue by curbing prescription opioids and the pendulum has swung too far in the direction of severely limiting prescription opioids, without acknowledgement that opioids have legitimate uses for persons suffering from chronic pain. Similar to the opioid crisis, interventional pain management procedures have been affected by various policies being applied to reduce overuse, abuse, and finally utilization. Medical policies have been becoming more restrictive with reduction of access to certain procedures, with the pendulum swinging too far in the direction of limiting interventional techniques. Recent utilization assessments have shown a consistent decline for most interventional techniques, with a 18.7% decrease from 2019 to 2020. The causes for these dynamic changes are multifactorial likely including the misapplication of the 2016 Centers for Disease Control and Prevention (CDC) guidelines for prescribing opioids for chronic pain, the relative ease of access to illicit synthetic opioids and more recently issues related to the COVID-19 pandemic. In addition, recent publications have shown association of dose tapering with overdose or mental health crisis among patients prescribed long-term opioids. These findings are leading to the hypothesis that federal guidelines may inadvertently be contributing to an increase in overall opioid deaths and diminished access to interventional techniques. Together, these have resulted in a fourth wave of the opioid epidemic. METHODS: A narrative review. RESULTS: The fourth wave results from a confluence of multiple factors, including misapplication of CDC guidelines, the increased availability of illicit drugs, the COVID-19 pandemic, and policies reducing access to interventional procedures. The CDC guidelines and subsequent regulatory atmosphere have led to aggressive tapering up to and including, at times, the overall reduction or stoppage of opioid prescriptions. Forced tapering has been linked to an increase of 69% for overdoses and 130% for mental health crisis. The data thus suggests that the diminution in access to opioid prescriptions may be occurring simultaneously with an increase in illicit narcotic use. Combined with CDC guidelines, the curbing of opioid prescriptions to medically needed individuals, among non-opioid treatments, interventional techniques have been affected with declining utilization rates and medical policies reducing access to such modalities. CONCLUSION: The opioid overdose waves over the past three decades have resulted from different etiologies. Wave one was associated with prescription opioid overdose deaths and wave two with the rise in heroin and overdose deaths from 1999 to 2013. Wave three was associated with a rise in synthetic opioid overdose deaths. Sadly, wave four continues to escalate with increasing number of deaths as a confluence of factors including the CDC guidelines, the COVID pandemic, increased availability of illicit synthetic opioids and the reduction of access to interventional techniques, which leads patients to seek remedies on their own.

Measuring Cervical Rotation During Telehealth

INTRODUCTION: Measuring cervical rotation virtually can be challenging during telehealth. The objective of this study was to proof the concept of measuring cervical rotation virtually during telehealth. METHODS: Subjects were instructed to sit in a chair with back supported and face to a computer with video conferencing platform communicating remotely with another computer. The subjects were instructed to rotate their neck from 0° to the end range with increments of 10°. Cervical rotation (CRoM) was calculated based on the changes of the distance between the subject's eyes on the screenshot. Data analysis included descriptive analysis, Pearson correlation, and Bland-Altman analysis. RESULTS: The mean CRoM was 0.0 (SD 0.0), 14.3 (3.4), 28.5 (5.1), 39.9 (5.9), 49.2 (6.5), 57.7 (6.8), 65.5 (6.9), 72.6 (5.5), and 80.8° (3.7°) from 0 to 80° in 10° increments, respectively. Pearson correlation coefficient (r) was 0.99, indicating a very high correlation. The Bland-Altman analysis revealed that 91.7% (111 out of 121) of the CRoM fell within the limits of agreement (95% confidence interval). DISCUSSION: Cervical rotation can be measured virtually using the changes of the distance between subject's eyes. No additional devices are required so it would work well for most patients.

Hospice Emergency Planning and COVID-19.

Objectives: Centers for Medicare and Medicaid Services requirements for Emergency Preparedness Planning (EPP) by hospice organizations significantly increased in 2017. This study seeks to assess the involvement of various hospice personnel in EPP before and since the onset of the novel coronavirus disease COVID-19 pandemic. Methods: A link to an anonymous online survey was sent to members of the American Academy of Hospice and Palliative Medicine and the Hospice and Palliative Nurses Association, targeting members involved in hospice care in the United States. A descriptive analysis of the data was performed. Results: Prior to the pandemic, 39.8% of respondents were "moderately" or "very" involved with the development and revisions of the Emergency Preparedness Plan. Since the beginning of the pandemic, this increased to 59%, which largely occurred among physicians. Clinical Nurse and Nurse Practitioner involvement in development/revisions remained low. Approximately 30% of respondents desired more involvement across the areas of EPP. Conclusion: The involvement of personnel of various disciplines is varied and the involvement of physicians appears to have increased with the onset of the COVID-19 pandemic. A notable portion of personnel desired more involvement across all aspects of EPP. More research is needed in this important but little-understood area.

The Centers for Medicare and Medicaid Services (CMS) COVID-19 Brief: Unsettling Racial and Ethnic Health Disparities.

On June 22, 2020, the Centers for Medicare and Medicaid Services (CMS) unveiled an aggregate data set on the impact of the coronavirus disease 2019 (COVID-19) on its beneficiaries. The CMS brief is especially noteworthy for offering COVID-19-related racial and ethnic health disparity data on a national scale, thereby extending reports heretofore limited to states, cities, or health systems. The CMS COVID-19 brief exposes distressing racial and ethnic health disparities. It is the objective of this commentary to trace the origins of the CMS COVID-19 brief, discuss its salient findings, and consider its implications.

Achieving Equity in Telehealth: "Centering at the Margins" in Access, Provision, and Reimbursement.

The SARS-CoV-2 epidemic has led to rapid transformation of health care delivery and access with increased provision of telehealth services despite previously identified barriers and limitations to this care. While telehealth was initially envisioned to increase equitable access to care for under-resourced populations, the way in which telehealth provision is designed and implemented may result in worsening disparities if not thoughtfully done. This commentary seeks to demonstrate the opportunities for telehealth equity based on past research, recent developments, and a recent patient experience case example highlighting benefits of telehealth care in underserved patient populations. Recommendations to improve equity in telehealth provision include improved virtual visit technology with a focus on patient ease of use, strategies to increase access to video visit equipment, universal broadband wireless, and inclusion of telephone visits in CMS reimbursement criteria for telehealth.

Examining the Emergency Medical Treatment and Active Labor Act: impact on telemedicine for neurotrauma.

The Emergency Medical Treatment and Active Labor Act (EMTALA) protects patient access to emergency medical treatment regardless of insurance or socioeconomic status. A significant result of the COVID-19 pandemic has been the rapid acceleration in the adoption of telemedicine services across many facets of healthcare. However, very little literature exists regarding the use of telemedicine in the context of EMTALA. This work aimed to evaluate the potential to expand the usage of telemedicine services for neurotrauma to reduce transfer rates, minimize movement of patients across borders, and alleviate the burden on tertiary care hospitals involved in the care of patients with COVID-19 during a global pandemic. In this paper, the authors outline EMTALA provisions, provide examples of EMTALA violations involving neurosurgical care, and propose guidelines for the creation of telemedicine protocols between referring and consulting institutions.

The COVID-19 Catalyst: Analysis of a Tertiary Academic Institution's Rapid Assimilation of Telemedicine.

INTRODUCTION: The COVID-19 pandemic forced all urology practices to reconsider the necessity of face-to-face office encounters. Seeking to reduce patient exposure, our urologic oncology office made an immediate transition to telemedicine and this study reports our experience. METHODS: Beginning March 17, 2020 the urologic oncology department committed to see all patients via telemedicine, unless they needed a cystoscopy for high grade urothelial cell carcinoma or recent gross hematuria, or required removal of a Foley catheter or surgical drain. March 17 was assigned day 1, and for the next 14 days rates of face-to-face, audio and audiovisual encounters were recorded. A telephone survey was conducted with all patients who participated in an audiovisual encounter. RESULTS: In analyzing the numbers of face-to-face, audio and audiovisual encounters, after day 5 more patients participated in audiovisual encounters than any other modality. By day 10 no nonessential face-to-face encounter occurred. There was an 80.4% response rate to our survey. Average patient account setup time was 10.5 minutes and 35.1% required assistance from our office to set up their account, averaging 7.1 minutes. No-show rates of face-to-face encounters were significantly higher than for audiovisual encounters (face-to-face 67%, audiovisual 17%, p <0.001). Overall 82% of patients surveyed were likely to elect for a telemedicine encounter over a face-to-face encounter for a routine visit during future flu seasons. CONCLUSIONS: The current study describes the initial adoption, early clinical experience and patient impressions of rapid implementation of telemedicine during the COVID-19 pandemic.