FDA Authorizes Two COVID-19 Vaccines, At-Home Test, More Treatments

As the COVID-19 pandemic continues to claim lives and attack the health of tens of thousands daily, the FDA continues efforts to bring treatments and tests to the public. In December, this included emergency use authorizations (EUA) for the first-ever vaccines for the virus, two new treatments, and one new test.

It must be noted that an EUA is not an FDA approval; an EUA is a declaration that circumstances exist to justify the emergency use of drugs and biological products that have not been FDA-approved, particularly when no other effective alternatives are available, assuming the benefits appear to outweigh the risks.

FDA Issues EUA for First COVID-19 Vaccine

On December 11, 2020, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.

Read the full FDA announcement here.

FDA Issues EUA for Second COVID-19 Vaccine

On December 18th, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.

The vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. After a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

Moderna COVID-19 Vaccine is administered as a series of two doses, one month apart. The available safety data to support the EUA include an analysis of 30,351 participants enrolled in an ongoing randomized, placebo-controlled study conducted in the U.S. Read the full FDA announcement here.

FDA Issues EUA to Baricitinib and Remdesivir for Hospitalized COVID-19 Patients

The FDA issued an emergency use authorization (EUA) for the drug combination of baricitinib and remdesivir for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized patients requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)

Baricitinib is FDA-approved for the treatment of moderately to severely active rheumatoid arthritis, while remdesivir is FDA-approved for the treatment of COVID-19 in hospitalized COVID-19 patients weighing 40 kilogram (88 pounds) or more.

Drug information, contraindications, adverse effects, and other considerations are available for both individual drugs in their respective drug labels. Click here for more information on remdesivir. Click here for more information on baricitinib.

FDA Issues EUA for Casirivimab and Imdevimab for Mild-to-Moderate COVID-19

The FDA issued an EUA for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in patients who are at high risk for progressing to severe COVID-19.

These drugs are investigational monoclonal antibodies; monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses. Casirivimab and imdevimab are monoclonal antibodies that are specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells.

Casirivimab and imdevimab must be administered together by intravenous (IV) infusion. Casirivimab and imdevimab are not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. A benefit of casirivimab and imdevimab treatment has not been shown in patients hospitalized due to COVID-19. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

FDA Issues EUA to First At-Home Test with At-Home Results

The FDA issued an EUA to the Lucira COVID-19 All-In-One Test Kit, a single-use COVID-19 test that individuals can use at home, on their own, which delivers results in 30 minutes or less.

The test kit has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider. It is also authorized for use in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages, but samples must be collected by a healthcare provider when the test is used at the POC for individuals younger than 14 years old.

The test is currently authorized for prescription use only.

The test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus.


Tags: COVID-19, FDA, EUA, emergency use authorization, remdesivir, baricitinib, casirivimab, imdevimab, Lucira, testing


The Patient Experience in Perspective: Applying Empathy to the Work Comp Claims Process

Patient empathy has been a popular topic within the healthcare industry over the past two decades. As healthcare organizations began focusing on the patient ‘experience of care’ as a measure of success, demonstrating empathy became an important goal for individual healthcare professionals, as well as overall patient engagement programs.

In workers’ comp, there is increasing support for a more empathetic and patient-centric claims model, and with good reason. A poor claims experience is not simply a matter of dissatisfaction on the part of the injured worker. A strong correlation has been reported between the claims process experience and return to work status. According to one study, injured workers who had a negative or neutral claim experience were less likely to have returned to work than those who had a positive experience – 65% as compared to 84% – when controlling for all other factors.1 In addition, negative interactions during the claims process can cause or exacerbate psychosocial factors, which can impact worker health in both the short and long term.2

The Workers’ Comp Patient Experience

Although the degree of injury or illness can vary, the majority of employees who file workers’ compensation claims require medical attention and, therefore, become patients. And their experience as patients may be inferior to those covered by other types of insurance. According to a recent study, workers’ comp patients are less satisfied with their medical providers than other payer patients (including private insurance, Medicare and Medicaid) with 59% of workers’ comp patients saying they would recommend their providers, as compared to 79% of non-workers’ comp patients.3 And a recent Healthesystems’ study found that 60% of patients who had initial medical exams reported a negative provider experience.4

But medical providers are not the only driver of unsatisfactory patient experience. A review of multiple qualitative studies regarding injured workers’ interactions with employers, insurers, and healthcare providers found that a majority of injured workers experience negative interactions at every stage of the claims process.2 And approximately 70% of patients who were referred to specialists were satisfied with the care they received, but only 59% were satisfied with how that care was coordinated…5

Continue reading the article in full at RxInformer.


Tags: RxInformer, empathy, engagement, patient, program design


IQVIA Reports on Telemedicine Trends and Opportunities

The IQVIA Institute for Human Data Science, a multinational health information technology and research company, published Telehealth Transformation: Moving from Crisis Response to Population Health Solutions, which highlights telemedicine trends during the COVID-19 outbreak and illuminates opportunities to expand telehealth to support population health management.

According to data from the Centers for Medicare and Medicaid Services (CMS), weekly telemedicine visits were at 14,000 per week pre-pandemic, jumping to 1.7 million per week in the last week of April 2020. While in-person visits have resumed, numbers still remain high.

Telemedicine rates prior to the pandemic made up less than 1% of medical visits, but they have increased ten-fold during the pandemic. Also of note: pre-pandemic, a majority of telemedicine visits were focused on mental health. While such visits have increased, telemedicine has come to mirror broader populations, with chronic conditions like hypertension and diabetes contributing to more visits.

The report also goes into detail how telemedicine can benefit four different patient populations, including:

  • Elderly patients
  • Chronic disease patients
  • Immunocompromised patients
  • Behavioral health patients

The 58-page report contains several insights and areas of opportunity, specifically highlighting how other aspects of telemedicine, beyond virtual visits, can benefit patients via the use of other technologies. Key highlights include:

  • 4 in 10 physicians are, at best, only “somewhat comfortable” with current technology
  • Cognitive artificial intelligence (AI) products can initiate conversations to help elderly patients stay in touch with family or loved ones, and engage in healthy behaviors, such as medication adherence
  • Interoperable patient engagement platforms can help with care coordination
  • Disease detection and progression analytics can help with prevention and detection measures for chronic disease populations and immunocompromised populations
  • Wearable devices can be used on a variety of patients to record health metrics, where AI functionality can check for inconsistencies in biometric data
  • Digital health apps can help mental health patients cope with symptoms, offering calming repetitive actions for addictions or to nurture behavior modification

Tags: telehealth, telemedicine, IQVIA, technology, CMS, COVID-19


New York Prepares to Launch New Claim Portal

New York is preparing to launch a limited release of their new claim portal, OnBoard, a platform meant to eliminate many paper processes and replace various legacy systems within the state, at the beginning of 2021.

This change, having passed various rounds of legislative and regulatory approval, signals a growing acknowledgement that technology must be embraced to improve the claims processes within workers’ comp. New York has already adopted or will soon be adopting several of the foundational regulations which will require use of the portal, which is expected to become mandatory for all providers by July 2021.

Since Summer 2019, the New York Workers’ Compensation Board (WCB) has been working to launch OnBoard, stating that this portal will provide users access to real-time data to speed up the claims process.

OnBoard users will be able to access the following data and functions with the limited release:

  • Medical records
  • Medical and pharmaceutical prior authorization and variance requests
  • Resolution of medical fee disputes
  • Reporting requirements such as first reports of injury
  • Automated emails or text messages for when requests are approved or denied

The portal is designed to be available to injured workers, their representatives, carriers and medical providers. Regulatory adjustments allow not only traditional providers to access the portal, but also physician assistants, occupational therapists and acupuncturists.

A full release is planned for 2023, at which point most WCB-required claim forms will be available digitally, pre-populated with known data, guiding users on how to fill necessary information.

An application programming interface (API) will be available as part of the full release of OnBoard in 2023 for stakeholders to communicate directly between organizational computer systems and the Board to automate the submittal of eForms.

WCB already held initial provider trainings for OnBoard, and they have posted several informational videos on their YouTube channel.


Tags: New York, OnBoard, portal, claims portal, claims management, innovation


Dr. Robert Goldberg Discusses Congressional Marijuana Vote with WorkersCompensation.com

The U.S. House of Representatives passed the MORE Act in early December, a bill written to decriminalize and tax marijuana at the federal level. The bill now sits with the Senate, where most believe it is unlikely to advance. Regardless, this is the first time that comprehensive legislation to decriminalize marijuana has passed the full House or Senate. The vote comes at a time when most Americans live in states where marijuana is legal in some form, and national cannabis policy has lagged behind changes at the state level.

This divide has created a host of problems in regulating medical marijuana use, which impacts workers’ compensation as some states require workers’ comp payers to reimburse medical marijuana on certain claims.

WorkersCompensation.com recently discussed how this momentous vote could be an important step towards furthering medical research, reaching out to industry experts for their opinion on the matter, including Healthesystems Chief Medical Officer, Robert Goldberg, MD, FACOEM.

Dr. Goldberg was quoted saying:

“The medical community and the pharma industry could perform the robust research that is sorely needed on clinical safety and effectiveness, dose formulations and pharmacology, the dose-response curve, and workplace/public safety. Once cannabis is no longer Schedule I, physicians could prescribe, pharmacists could dispense, patients could legally acquire and use in all 50 states, and payers would no longer be restrained by federal or state regulations to reimburse for medically necessary and appropriate prescriptions/ recommendations.”

For more information, read the article in full.


Tags: Robert Goldberg, Goldberg, Healthesystems, WorkersCompensation.com, marijuana