Tag: coronavirus

Axxess Survey Confirms PPE and Cash Flow Seen As Significant Challenges During Coronavirus (COVID-19) Crisis

a close up of a flower: The ominous, omnipresent 3D illustration of COVID-19 (coronavirus) is the work of two accomplished CDC artists. Here's how they created the now-iconic image.The coronavirus (COVID-19) has had a significant impact on healthcare at home providers’ ability to see or care for patients, and the much-publicized lack of personal protective equipment (PPE) is a very real issue, according to findings of a survey conducted by healthcare technology leader Axxess.

More than 80 percent of respondents said the virus has had an impact on their organization’s ability to see or care for patients, and three-fourths of respondents said they do not have adequate PPE for staff.

The survey of thousands of home-based care providers from organizations of all sizes from March 25-30 confirmed that agencies have a critical need for PPE, including N95 masks, gloves, face masks, gowns and hand sanitizer.”

In addition, billing or cash flow has been interrupted for nearly 60 percent of respondents’ organizations, and more than half of respondents indicated their organization has experienced staffing challenges as an impact of the virus.

“Understanding how challenged providers are at this uncertain time, we appreciate everyone who took the time to help provide visibility into the needs of the industry,” said John Olajide, founder and CEO of Axxess. “Our brief survey was designed to give a voice to our heroes on the frontlines of caring for those most vulnerable to coronavirus.”

The survey, which included respondents from all levels of organizations, including management and caregivers directly working with patients and clients, showed nearly half of respondents have a negative view of coronavirus’ (COVID-19) eventual impact on their business.

The long-term impact of coronavirus (COVID-19) on the industry is less certain, with about a third of respondents feeling it would ultimately be positive, a third feeling it would be negative and about a third having neutral feelings.

“I am incredibly proud to be part of such a caring community,” Olajide said. “We can’t know how long this crisis will last, but it should be reassuring to all of us that we are all working together and demonstrating leadership, providing expertise, displaying innovation and sharing resources.”

The full survey report is available in the Axxess COVID-19 Resource Center.

Flattening The Curve With Telehealth

Response from Avi Price, COO, Uniper Care.

Avi PriceThe Trump administration temporarily changed the policy for Centers for Medicare & Medicaid Services (CMS) allowing healthcare providers to have phone-only visits with patients, which is a major breakthrough in the industry and one that was not allowed before.

With the coronavirus being spread throughout the United States, the administration understands the importance of social distancing and the pivotal role  that telehealth will play in keeping patients healthy. What is necessary to support the amount of patients today is an economically sustainable, scalable and immediate telecare solution that is available to anyone, regardless of income, age, or location.

The way to keep the general population healthy, is in a fight to flatten the curve and protect most specifically older adults and those at-risk from COVID-19. Telehealth is likely the most effective way to provide care to those who need it and minimize exposure to the virus for the both the patient and the doctor. Right now the hospital systems are overwhelmed with the sudden influx of patients from this virus and telecare’s primary role is to treat  patients remotely, reducing the pressure being put on the hospital systems.

Another important factor is the effects that social isolation has placed on older adults and how that will impact their overall physical and mental well-being. We created Uniper to provide a familiar service for older adults, right on their TV screens, mobile phone or desktop to have access to life: their communities, friends, family and physicians so that they can obtain much needed care, from a distance.

Uniper is designed to be economically sustainable, scalable, and accessible to anyone that needs it to help them thrive during these unusual times.

Elsevier Launches Veridata Electronic Data Capture (EDC) and Offers Free Access To Help Researchers Studying COVID-19

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Elsevier, a global leader in information analytics specializing in science and health, today introduces Veridata EDC, a secure, compliant and user-friendly platform to capture patient data for clinical research.

Veridata EDC is a next-generation version of Elsevier’s MACRO, a solution that has been proven in commercial and not-for-profit clinical research for more than 20 years.

To assist researchers working to develop vaccines and other therapies for COVID-19, Elsevier has pledged to make Veridata EDC available for free. Interested clinical researchers can contact Elsevier customer support via e-mail at covid19@elsevier.com and apply for a demo account. Following the necessary compliance training, they will receive a free 12-month license.

“As researchers around the globe unite to fight COVID-19, they urgently need ways to streamline data collection and facilitate workflows in their studies,” said Olaf Lodbrok, Senior Vice President for Precision Medicine, Global Clinical Solutions, Elsevier. “Veridata EDC is a platform that optimizes data to help them find untold insights faster and more easily.

“COVID-19 is perhaps the biggest challenge in healthcare today. Elsevier is proud to offer clinical researchers a free solution that can transform data points into knowledge to improve clinician collaboration and hopefully patient outcomes.”

Veridata EDC provides clinical researchers with secure and compliant electronic data capture to ensure that the rights, safety and well-being of clinical trial participants are protected. Its intuitive user interface means researchers can quickly input, monitor and run reports to collect accurate and reliable subject data for analysis.

“Veridata EDC breaks down the barriers to research for COVID-19 and beyond. We believe the long legacy of Veridata EDC, combined with its sophisticated functionality, provides the research community with a solution they can trust to further medical discovery,” said Dr. John Danaher, president of global clinical solutions, Elsevier. “Along with Elsevier’s Novel Coronavirus Information Center, our one-stop access to the latest medical and scientific information on coronavirus from across Elsevier’s journals and clinical resources, we are pleased to be a company helping clinicians and clinical researchers on the front lines of fighting this outbreak.”

Trump Administration Makes Sweeping Regulatory Changes To Help U.S. Healthcare System Address COVID-19 Patient Surge

“Every day, heroic nurses, doctors, and other healthcare workers are dedicating long hours to their patients. This means sacrificing time with their families and risking their very lives to care for coronavirus patients,” said CMS Administrator Seema Verma. “Front line healthcare providers need to be able to focus on patient care in the most flexible and innovative ways possible. This unprecedented temporary relaxation in regulation will help the healthcare system deal with patient surges by giving it tools and support to create non-traditional care sites and staff them quickly.”

Other temporary CMS waivers and rule changes dramatically lessen administrative burdens, knowing that front line providers will be operating with high volumes and under extraordinary system stresses.

CMS recently approved hundreds of waiver requests from healthcare providers, state governments, and state hospital associations in the following states: Ohio; Tennessee; Virginia; Missouri; Michigan; New Hampshire; Oregon; California; Washington; Illinois; Iowa; South Dakota; Texas; New Jersey; and North Carolina. With today’s announcement of blanket waivers, other states and providers do not need to apply for these waivers and can begin using the flexibilities immediately.

Administrator Verma added that she applauds the Mar. 23, 2020, pledge by America’s Health Insurance Plans (AHIP) to match CMS’s waivers for Medicare beneficiaries in areas where in-patient capacity is under strain. “It’s a terrific example of public-private partnership and will expand the impact of Medicare’s changes,” Verma said.

CMS’s temporary actions announced today empower local hospitals and healthcare systems to:

  • Increase Hospital Capacity – CMS Hospitals Without Walls:

CMS will allow communities to take advantage of local ambulatory surgery centers that have canceled elective surgeries, per federal recommendations. Surgery centers can contract with local healthcare systems to provide hospital services, or they can enroll and bill as hospitals during the emergency declaration as long as they are not inconsistent with their State’s Emergency Preparedness or Pandemic Plan. The new flexibilities will also leverage these types of sites to decant services typically provided by hospitals such as cancer procedures, trauma surgeries and other essential surgeries.

CMS will now temporarily permit non-hospital buildings and spaces to be used for patient care and quarantine sites, provided that the location is approved by the State and ensures the safety and comfort of patients and staff. This will expand the capacity of communities to develop a system of care that safely treats patients without COVID-19, and isolate and treat patients with COVID-19.

CMS will also allow hospitals, laboratories, and other entities to perform tests for COVID-19 on people at home and in other community-based settings outside of the hospital. This will both increase access to testing and reduce risks of exposure. The new guidance allows healthcare systems, hospitals, and communities to set up testing sites exclusively for the purpose of identifying COVID-19-positive patients in a safe environment.

In addition, CMS will allow hospital emergency departments to test and screen patients for COVID-19 at drive-through and off-campus test sites.

During the public health emergency, ambulances can transport patients to a wider range of locations when other transportation is not medically appropriate. These destinations include community mental health centers, federally qualified health centers (FQHCs), physician’s offices, urgent care facilities, ambulatory surgery centers, and any locations furnishing dialysis services when an ESRD facility is not available.

Physician-owned hospitals can temporarily increase the number of their licensed beds, operating rooms, and procedure rooms. For example, a physician-owned hospital may temporarily convert observation beds to inpatient beds to accommodate patient surge during the public health emergency.

In addition, hospitals can bill for services provided outside their four walls. Emergency departments of hospitals can use telehealth services to quickly assess patients to determine the most appropriate site of care, freeing emergency space for those that need it most. New rules ensure that patients can be screened at alternate treatment and testing sites which are not subject to the Emergency Medical Labor and Treatment Act (EMTALA) as long as the national emergency remains in force. This will allow hospitals, psychiatric hospitals, and critical access hospitals (CAHs) to screen patients at a location offsite from the hospital’s campus to prevent the spread of COVID-19.

  • Rapidly Expand the Healthcare Workforce:

Local private practice clinicians and their trained staff may be available for temporary employment since nonessential medical and surgical services are postponed during the public health emergency. CMS’s temporary requirements allow hospitals and healthcare systems to increase their workforce capacity by removing barriers for physicians, nurses, and other clinicians to be readily hired from the local community as well as those licensed from other states without violating Medicare rules.

These healthcare workers can then perform the functions they are qualified and licensed for, while awaiting completion of federal paperwork requirements.

CMS is issuing waivers so that hospitals can use other practitioners, such as physician assistants and nurse practitioners, to the fullest extent possible, in accordance with a state’s emergency preparedness or pandemic plan. These clinicians can perform services such as order tests and medications that may have previously required a physician’s order where this is permitted under state law.

CMS is waiving the requirements that a certified registered nurse anesthetist (CRNA) is under the supervision of a physician. This will allow CRNAs to function to the fullest extent allowed by the state, and free up physicians from the supervisory requirement and expand the capacity of both CRNAs and physicians.

CMS also is issuing a blanket waiver to allow hospitals to provide benefits and support to their medical staffs, such as multiple daily meals, laundry service for personal clothing, or child care services while the physicians and other staff are at the hospital and engaging in activities that benefit the hospital and its patients.

CMS will also allow healthcare providers (clinicians, hospitals and other institutional providers, and suppliers) to enroll in Medicare temporarily to provide care during the public health emergency.

  • Put Patients over Paperwork:

CMS is temporarily eliminating paperwork requirements and allowing clinicians to spend more time with patients. Medicare will now cover respiratory-related devices and equipment for any medical reason determined by clinicians so that patients can get the care they need; previously Medicare only covered them under certain circumstances.

During the public health emergency, hospitals will not be required to have written policies on processes and visitation of patients who are in COVID-19 isolation. Hospitals will also have more time to provide patients a copy of their medical record.

CMS is providing temporary relief from many audit and reporting requirements so that providers, healthcare facilities, Medicare Advantage health plans, Medicare Part D prescription drug plans, and states can focus on providing needed care to Medicare and Medicaid beneficiaries affected by COVID-19.

This is being done by extending reporting deadlines and suspending documentation requests which would take time away from patient care.

  • Further Promote Telehealth in Medicare:

Building on prior action to expand reimbursement for telehealth services to Medicare beneficiaries, CMS will now allow for more than 80 additional services to be furnished via telehealth. During the public health emergencies, individuals can use interactive apps with audio and video capabilities to visit with their clinician for an even broader range of services. Providers also can evaluate beneficiaries who have audio phones only.

These temporary changes will ensure that patients have access to physicians and other providers while remaining safely at home.

Providers can bill for telehealth visits at the same rate as in-person visits. Telehealth visits include emergency department visits, initial nursing facility and discharge visits, home visits, and therapy services, which must be provided by a clinician that is allowed to provide telehealth. New as well as established patients now may stay at home and have a telehealth visit with their provider.

CMS is allowing telehealth to fulfill many face-to-face visit requirements for clinicians to see their patients in inpatient rehabilitation facilities, hospice and home health.

CMS is making it clear that clinicians can provide remote patient monitoring services to patients with acute and chronic conditions, and can be provided for patients with only one disease. For example, remote patient monitoring can be used to monitor a patient’s oxygen saturation levels using pulse oximetry.

In addition, CMS is allowing physicians to supervise their clinical staff using virtual technologies when appropriate, instead of requiring in-person presence.

For additional background information on the waivers and rule changes, go to: https://www.cms.gov/newsroom/fact-sheets/additional-backgroundsweeping-regulatory-changes-help-us-healthcare-system-address-covid-19-patient

For more information on the COVID-19 waivers and guidance, and the Interim Final Rule, please go to the CMS COVID-19 flexibilities webpage: https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers.

These actions, and earlier CMS actions in response to COVID-19, are part of the ongoing White House Coronavirus Task Force efforts. To keep up with the important work the Task Force is doing in response to COVID-19, visit www.coronavirus.gov.  For a complete and updated list of CMS actions, and other information specific to CMS, please visit the Current Emergencies Website.

OneBlood To Collect Plasma From Recovered Coronavirus Patients As Potential Treatment Option

Graphic Standards | OneBloodOneBlood, the not-for-profit blood center serving Florida and other parts of the southeastern United States, will soon begin collecting plasma from people who have recovered from the coronavirus so it can be transfused to people with life-threatening coronavirus infection in hopes of aiding their recovery.

The experimental treatment is approved by the FDA to be used on an emergency basis and is called “COVID-19 convalescent plasma.”

People who recover from coronavirus infection have developed antibodies to the virus that remain in the plasma portion of their blood.  Transfusing the plasma that contains the antibodies into a person still fighting the virus can provide a boost to the patient’s immune system and potentially help them recover.

OneBlood is working closely with the Florida Department of Health to identify people who have recovered from COVID-19 to be potential donors. In addition to local efforts, OneBlood is also cooperating with the federal government and anticipates participating in a national-level initiative to be able to provide convalescent plasma when and where it is needed.

OneBlood is working quickly to implement the new protocols to meet the FDA criteria for COVID-19 convalescent plasma. OneBlood plans to begin collecting plasma from qualified donors in the coming weeks and also plans to start offering the therapeutic agent to hospitals to treat severely ill coronavirus patients. As one of the largest blood centers in the country, OneBlood already has the technology in place to be able to collect, test and process plasma from donors.

The potential donors will need to meet all the usual screening criteria for blood donation, plus pass additional FDA criteria, including:

In addition, the recipients of the plasma will also have to meet FDA criteria in order to qualify to receive this therapy for treating life-threatening COVID-19. (Click here for FDA report).

Globalizing Coronavirus Research Through Translation and Localization

In this, the day and age of the global coronavirus outbreak, the job of the medical translator and interpreter has never been more relevant. Resolving this global crisis involves a great deal of research and analysis, much of it in the form of clinical trials. All of the requisite research and analysis must not only be reported and published but accurately documented as well. Once all of the research from the clinical trials has been completed, the information must be made readily available.

The document translation must be completed by certified medical translators and disseminated globally in order for the research to be relevant and helpful. This is an absolutely crucial role during any medically related global crisis but the medical translation of the clinical trial documentation will ultimately be the key to bringing the COVID-19 global pandemic to a successful conclusion before it can get any worse for the people of the world.

In tandem with the need for medical translation is the localization of clinical trials, which requires additional paperwork that the medical translator must make accessible to the world.

Document Requirements for Domestic and International

According to the National Institute of Health, “One of the most common inspection findings in investigator site inspections is lack of reliable, accurate and adequate source documentation. This also happens to be the most common pitfall identified during sponsor audits. The importance of good documentation practice needs to be emphasized to investigator sites to ensure that the study results are built on the foundation of credible and valid data.”

One of the biggest concerns during the current global medical crisis is that many of the clinical trials will not be properly published at all. Of those that are, many will suffer due to the improper documentation and document recordings, and all this before medical document translation begins. Among the biggest culprits of under-reporting, clinical trials were many academic institutions where certified medical translators should be readily available, and clinical trial document requirements should not be a challenge.

A study from the US Food and Drug Administration which is responsible for the oversight and investigation of Clinical Trials in the United States, inadequate documentation records were one of the top causes of clinical trials being brought into question or having them dismissed completely.

Clinical Trial Audits were most commonly required according to the FDA because of the following reasons:

  1. failure to follow the investigational plan   (34%)
  2. inadequately informed consent form         (28%)
  3. inadequate/inaccurate records                 (27%)

The amount of documentation required to conduct a clinical trial is overwhelming on the best of days. Every one of the documents is absolutely relevant to the successful conclusion of the clinical trials being conducted by medical researchers.

This is especially true in terms of the current global Covid-19 pandemic. In terms of global clinical trials, translation services should work in support of the global effort, though this also requires that all of the documentation is in order, to begin with. Further, it relies on medical researchers working with a certified medical translation agency that also has the capacity to integrate and implement successful localization strategies to ensure the accuracy of the medical translations before they are distributed globally.

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Validic Announces Real-Time, Remote Symptom Monitoring To Address COVID-19 Health Crisis

As part of Validic‘s efforts to address the global coronavirus (COVID-19) outbreak, the company launched a real-time monitoring solution designed to observe, analyze and triage individuals remotely for the emergence of  COVID-19 symptoms.

COVID-19 Home Monitoring tracks a person’s body temperature, difficulty breathing, cough frequency and oxygen saturation. The solution provides real-time analysis and escalation of critical health data to care management teams, public health officials and/or human resource administrators.

In an effort to empower people on the frontlines of this health crisis, the solution is designed for rapid deployment and scale:

  • Triage individuals, monitor health metrics and codify next steps
  • Bulk enroll thousands of individuals quickly
  • Automate measurement reminders via text and/or email

Triggered alerts will notify program administrators or clinicians as a person’s symptoms worsen, improve, or remain static – or as a quarantine period ends with no symptoms present.

“Given our expertise in personal health data and remote patient monitoring, we’ve been working to quickly develop and launch a custom COVID-19 solution that allows for proactive, remote interventions using real-time data. At no time in recent history has there been a higher imperative to use distance monitoring to keep people alive and healthy,” Drew Schiller, CEO of Validic, said.

“Everyone’s safety, especially those individuals who cannot self-isolate – like our emergency responders, nurses, and sanitation workers – need to be a foremost priority, especially at this time. We want all healthcare professionals and employers to be able to leverage industry-leading remote monitoring capabilities to help people impacted by or potentially exposed to coronavirus.”

As health systems, health plans and employers across the country continue to face an urgent need to monitor people for the emerging symptoms of COVID-19, Validic is offering this solution with a flexible, month-to-month plan that ensures organizations can access the platform without financial constraints.

To learn more about COVID-19 Home Monitoring, visit https://www.covidmonitoring.com/.

Use of Telemedicine To Surge In U.S. As Regulations Change In Response To Coronavirus

Use of telemedicine in the U.S. has been low to date. However, asexpected, it is expected that demand for these services will increase dramatically over the next few months because of the coronavirus (COVID-19) crisis, says GlobalData, a leading data and analytics company.

Telemedicine has been touted as a critical strategy during the COVID-19 emergency to limit the risk of person-to-person transmission of the virus, prevent emergency rooms from being inundated, reduce barriers to screening, and allowing those with moderate symptoms to be treated from home. Teladoc Health, a telehealth provider, announced that patient visit volume had increased by 50% since the previous week and was continuing to rise.

Kathryn (Gleeson) WhitneyKathryn Whitney, MSc, director of thematic analysis at GlobalData, said: “Prior to the COVID-19 crisis, telemedicine had never reached its full potential in the US, with several barriers preventing its widespread uptake. These include lack of reimbursement and restrictions affecting access for rural populations, general lack of awareness of these services, and the desire of the sick to see their physician in person.”

Since early March, regulations in the US governing the use of telemedicine have changed regularly, which will expand access to services during the COVID-19 emergency, particularly for Medicare beneficiaries who are deemed at high risk for the virus. In certain states, including California and New York, officials have also announced that payers must offer telehealth services as part of their emergency plans. In Massachusetts, payers must cover the COVID-19 testing and treatment via telehealth, and cannot impose cost sharing via co-pays, deductibles, or coinsurance, and prior authorization is not required to receive treatment via telehealth.

Whitney continues: “Recent changes to regulations by the U.S. government will remove many of the financial barriers to telehealth and drive the use of these services, particularly among older and vulnerable populations. People will also become more aware of these types of services, given amount of information being disseminated by the government, hospitals, healthcare systems and payers.

“As more U.S. cities and states begin to lock down and social distancing becomes the new normal for the foreseeable future, Americans are likely to change their views on telemedicine. With the ongoing risk of virus transmission, people will be eager to avoid hospitals and get screened and receive care from the safety of their own homes.”