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 email@example.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.”
“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.
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, 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:
COVID-19 convalescent plasma must only be collected from recovered individuals if they are eligible to donate blood
Required testing must be performed and the donation must be found suitable
Prior diagnosis of COVID-19 documented by a laboratory test
Complete resolution of symptoms at least 14 days prior to donation
Have a negative result for COVID-19
Meet all standard FDA blood donation requirements
As with all transfusions, the donor and the patient will need to have compatible blood types
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).
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:
failure to follow the investigational plan (34%)
inadequately informed consent form (28%)
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.
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.
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 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.”
By Dr. Jason Hallock, MD, chief medical officer, SOC Telemed.
On March 13, President Trump declared the novel coronavirus (COVID-19) pandemic a national emergency. The declaration opens more than $42 billion in federal funding to combat the virus by expanding resources in key areas, including telehealth across the nation. While COVID-19 is novel there’s nothing new about telehealth solutions that are now moving to the forefront care in light of this virus.
Funding will support an increase in COVID-19 testing and expand telehealth services to virtually care for patients. HHS can waive licensing regulations to allow out-of-state physicians to treat patients via telehealth wherever outbreaks occur. And, critically, the declaration of emergency allows for $500 million in Medicare waivers for telehealth restrictions.
The action comes at a critical moment, as the U.S. health care system is confronted for the first time in its modern history with the possibility of a hospital capacity crisis. If too many COVID-19 positive cases descend on our hospitals at once, we could be in the unenviable position of lacking the onsite equipment, the beds, tests, staff and other resources to provide life-saving care for all. Such dark medical realities are already true elsewhere in the world.
As the contents of the national emergency declaration show, telemedicine is poised to play a key role in the fight against COVID-19. It’s not by accident.
While the virus spread rapidly to pandemic status, the reality is that the healthcare industry long anticipated the possibility of a fast-spreading global contagion. As we in the industry planned for the possibility of such an event, telemedicine was always among the solutions.
The role of telemedicine in the time of a pandemic is not an experiment or for use in a limited trial—it’s actively being used to treat COVID-19 today. In fact, the Centers for Disease Control and Prevention (CDC) continues to urge doctors and hospitals first to assess potentially infected patients remotely whenever possible, and to care for patients with mild COVID-19 symptoms from home using virtual check-ins.
The coronavirus is dangerous because of how easily it spreads from person to person. If you believe you have it or have been confirmed to have it through testing, then you will need to self-quarantine.
Self-quarantining is a precaution that everyone should aim to take if they have been in an infected area or are experiencing flu-like symptoms. Though the chances of you yourself dying or reaching a critical state are overall low, if you are infectious, you could pass the disease on to someone who is at risk. Those who are older or who have underlying health conditions are at risk of reaching a critical state if they catch the coronavirus. Quarantine yourself if you have a cold, take these precautions, and get better fast:
Try to Stay Away From Non-Infected Family Members
This can be difficult if you live in a small space, but if you can try to stay away from members of your family who aren’t sick as much as possible. This might mean further quarantining yourself to your room while testing is done or while you are sick. It might mean having your non-sick family member stay with a friend in the area instead. Go through your options to help reduce the risk of spreading the disease to others.
Order Food and Supplies to Your Door
When you are under self-quarantine, you won’t want to leave your home, even if it’s just to buy groceries. Thankfully there are many door-to-door options out there. Your grocery store might offer a delivery option, or you might have to go with a company like Uber Eats or Post Mates.
Do note that some companies have changed their policies in light of the coronavirus, so you might not see the delivery person, and instead have your order placed outside the door instead of handed to you.This also applies to supplies. There are many online retailers to help you bulk up, even for medical supplies like a finger bandage or medicine. Knowing how and where to shop for these items is going to be important when it comes to caring for and providing for your family under self-quarantine.
Catch the Cold
While you are sick, you will want to catch the cold, so to speak. Have tissues at the ready to cover your mouth or nose if you cough or sneeze. Immediately throw the tissue out and then wash your hands. This will help reduce the spread of the coronavirus in your own home.
The Centers for Medicare & Medicaid Services (CMS) issued a fact sheet with additional guidance for healthcare providers and patients about the telehealth benefits in the agency’s Medicare program. The fact sheet is part of a broader effort by CMS and the White House Task Force to ensure that all Americans – particularly those at high-risk of complications from the COVID-19 virus – are aware of easy-to-use, accessible benefits that can help keep them healthy while helping to contain the community spread of this disease.
“As we continue to learn about the COVID-19 virus, it’s important for all Americans, and particularly vulnerable populations who are at heightened risk, to be able to access their providers when they feel sick or have questions” said CMS Administrator Seema Verma. “Over the last three years, President Trump’s leadership and historic efforts have made it possible for doctors to bill for their time on the phone or video chat with patients to help triage medical issues. Today, a patient who is not feeling well can call their doctor to decide whether or not they need to go in for a visit, offering solutions and peace of mind immediately.”
CMS’ historic effort made virtual check-ins and other services that use telecommunications possible with new policies implemented in 2019 and 2020. These services are available right now to patients and their physicians, providing a great deal of flexibility and an easy way for patients who are concerned about illness to remain in their home avoiding exposure to others.
With the COVID-19 virus, there is an urgency to expand the use of virtual care to keep the beneficiaries with mild symptoms in their homes while increasing access to their provider’s office.
For the beneficiary, these benefits can be very helpful. For example, a Medicare beneficiary who is looking for advice about symptoms they are experiencing, can call their doctor and receive medical advice about whether he or she needs to see their doctor in person for a physical exam.
If they start to feel more ill, a virtual check-in allows a healthcare provider to offer recommendations about next steps and even take precautions for someone they are concerned may have the COVID-19 virus or flu before they step in the office or hospital putting others at risk. These check-ins are billable services and the Medicare coinsurance and deductible would apply to these services.
Medicare Advantage plans may also provide enrollees access to Medicare Part B services via telehealth in any geographic area and from a variety of places, including beneficiaries’ homes, as part of their benefit packages for a plan year.
Therefore, enrollees in Medicare Advantage plans that include coverage of such services may be available to receive clinically appropriate services for treatment of COVID-19 via telehealth from many sites, including their home.
Rimidi, a cloud-based software platform, announced the launch of its patient-reported outcomes survey app to help limit the spread of COVID-19 in healthcare settings. Currently, the app is in expedited beta testing by select U.S. health systems operating in the regions at the greatest risk of Coronavirus outbreak. Rimidi anticipates general availability of the app before the end of March 2020.
“One of the greatest challenges in China and across other countries that faced early COVID-19 outbreaks has been hospital-based transmission,” said Lucienne Ide, MD, PhD, founder of Rimidi. “With the app, we can help keep potentially infectious individuals from exposing other patients or staff in the healthcare system in waiting rooms, emergency rooms, or triage before they are identified and separated.”
Combatting Coronavirus Spread via Advanced EHR-integrated Technology
Along with their text message appointment reminder, patients are sent a brief COVID-19 screening survey inquiring about current symptoms and recent travel. Integrated within the electronic health record (EHR), patient responses are easily captured and analyzed by clinical teams. The survey respondents demonstrating potential risk of COVID-19 exposure, in accordance with the latest CDC guidelines, are immediately notified with the appropriate next steps of care and treatment options, while the healthcare system is confidentially made aware of the at-risk patient.
Ultimately, the simplicity and accessibility of Rimidi’s screening app will help minimize the spread and impact of COVID-19 in healthcare settings by reducing the number of undiagnosed patients interacting with patients seeking standard care. It will also limit exposure of healthcare staff to potentially infectious patients in settings that are not adequately prepared.
Dr. Ide added, “The need for such a screening app was advocated for in a JAMA article following the Ebola outbreak in 2014. Today, the potential COVID-19 public health emergency reinforces the healthcare industry’s need for interoperability and stronger data-sharing rules to ease the flow of information, which enables rapid deployment of a single application across multiple EHR platforms.”
Rimidi remains in close coordination with the Centers for Disease Control and Prevention and will incorporate new evidence and its evolving guidance into the screening app as it emerges. This may include ongoing remote monitoring and self-reporting by patients in quarantine, among other features.
For more information and to be notified when the app is widely available for healthcare systems, please visit rimidi.com/covid19.