FDA Approves Pfizer COVID-19 Vaccine, Booster Shots on the Way

In late August, the FDA officially approved the Pfizer-BioNTech COVID-19 vaccine, which will officially be marketed as Comirnaty. This is the first FDA-approved vaccine for the prevention of COVID-19 and potentially serious outcomes including hospitalization and death.

Until now, COVID-19 vaccines had only received emergency use authorization (EUAs). EUAs are declarations 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. Full FDA approval means that a drug has undergone the FDA’s full standard process for reviewing the quality, safety, and effectiveness of medical products.

Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease. More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.

Common side effects were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.

In related news, more developments have occurred regarding COVID-19 vaccine booster shots.

In early August, the FDA amended the EUAs for the Pfizer and Moderna vaccines to allow for an additional dose in certain immunocompromised individuals. The update was made specifically for those immunocompromised in a manner similar to those who have undergone solid organ transplant or those who are diagnosed with conditions considered to have an equivalent level of immunocompromise.

Roughly a week later, the White House announced plans to make COVID-19 boosters available for adults starting the week of September 20th. Boosters can only be administered eight months after an individual’s second dose of the Pfizer or Moderna vaccine, which means that the initial start of booster administration would apply only to early receivers of the vaccine, such as healthcare workers and nursing home residents.

The White House’s decision coincides with recommendations from the Department of Health and Human Services (HHS) and the CDC.

Following these updates, the FDA amended the EUA for the Pfizer COVID-19 vaccine to allow for the use of a single booster dose, to be administered at least six months after the completion of the primary series in certain populations.

Impacted populations include:

  • Individuals age 65 and older
  • Individuals age 18 to 64 at high risk of severe COVID-19
  • Individuals age 18 to 64 whose frequent institutional or occupational exposure to SARS-COV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19

The CDC then quickly endorsed this update.


Tags: COVID-19, Pfizer, Moderna, vaccine, Comirnaty, booster, CDC, EUA, drug approval, FDA


Applying AI to Leverage the Value of Unstructured Claims Data

This article was originally published by WorkCompWire, featuring Healthe’s Director of Enterprise Analytics, Mike Theis, in their Leaders Speak forum.

It’s estimated that up to 80 percent of the information contained in an electronic health record is unstructured and not readily accessible. Whether in clinician notes, physical therapist notes, or other text-based records, much of the information needed to facilitate return to work and to health is there — if we have the means to tap into it.

Every interaction between a care provider and an injured worker yields information that could be a significant piece of the puzzle – whether it’s information about comorbidities, social determinants of health, psychosocial factors, or medication- or treatment-specific risks. So when we’re looking at an injury, how do we understand those other factors to bring context to the complexity of the claim or the risk that an individual patient may be facing?

Enhancing Human Capabilities

Natural language processing (NLP) leverages artificial intelligence (AI) to help analytics systems understand and organize unstructured data. But I like to say that it’s more about augmented intelligence, rather than artificial intelligence. In other words, how do we build the right tools to provide stakeholders with the right information, at the right time, to make the best decision?

We’ve seen the most success by marrying the AI aspect with human expertise to produce the best outcome. For example, a Healthesystems clinical pharmacist may read through a thousand pages in a medical record during an independent pharmacotherapy evaluation. This effort is valuable in that it has often uncovered opportunities to help steer the trajectory of a claim toward a more positive and cost-effective outcome. But it is also time consuming. Enter NLP, the application of which can drive efficiencies in that process and extract key data elements for the clinician so that we can reduce the time it takes to review those medical records and intervene. Or, taking it a step further, by quickly identifying claims that would derive the greatest benefit from a clinician’s review, helping to prioritize when there is limited time.

Informing Population Management

Not only are AI and NLP technologies effective in extracting key information to move the needle on individual complex and high-cost claims, but also in feeding that data back into the analytics system to inform models looking at population health, helping claims organizations and their partners to stratify and segment the population more effectively.

As an example, we know that social determinants of health can have a significant impact on health outcomes, and some may be especially impactful to injured workers and their recovery. Patient populations with otherwise straightforward musculoskeletal injuries may have significantly different outcomes when a history of substance abuse intersects with the prescribing of opioids. Populations without a social support system or access to transportation may have significantly higher costs due to transportation needs or language barriers. The key is being able to connect the dots before the claim becomes complex, and an augmented approach to analytics using AI technologies can help inform future decisions related to patient populations impacted by these factors – whether it’s timely referrals for urine drug screening, or the foresight to anticipate higher-than-average transportation services on the claim.

Enhancing Program Management

AI-extracted data can also help measure and inform stakeholder behaviors and other aspects of program performance. How is each role performing within the system? Are the vendors scheduling services on time – and if not, where are the breakdown points? Are the providers or claims examiners requesting or approving services that conflict with your clinical strategies? How are the patients reporting outcomes and service results? That data is valuable, not just at a micro-level, but especially in analyzing and developing program management strategies to improve performance for all stakeholders.

The opportunities for NLP and other AI-based technologies are ripe for augmenting and accelerating some processes that are already successful in workers’ comp claims management – as well as creating brand new opportunities. I’m excited to see the impacts of this technology as it becomes more prevalent within our own programs at Healthe as well as the industry at large.

View the original article at WorkCompWire.


Tags: Mike Theis, AI, artificial intelligence, NLP, natural language processing, WorkCompWire, Leaders Speak


WCRI Publishes Report on Off-Label Gabapentinoid Use

The Workers’ Compensation Research Institute (WCRI) published a new study that examines the growing use of off-label gabapentinoids for work-related injuries.

Off-label prescribing – which can be an acceptable practice – is when doctors prescribe a drug to treat a condition, even though that drug has not been FDA-approved to treat that specific condition. Gabapentinoids are drugs indicated to treat epilepsy, as well as specific types of pain, such as nerve pain resulting from shingles or diabetes, or fibromyalgia. However, they are commonly prescribed off-label in workers’ comp to treat other types of pain beyond these indications.

As opioid utilization has decreased due to various pieces of opioid legislation, many have predicted that alternative medications for pain may see greater utilization. Like any drug group, gabapentinoids come with their own potential risks, and therefore it is important to note any significant increases in utilization.

This report examines the use of gabapentin (Neurotonin) and pregabalin (Lyrica) in over 482,000 work-related injuries and illnesses across 28 states from January 1, 2018 to March 31, 2019. Both gabapentin and pregabalin were among the top three drugs in terms of prescription drug spending nationally in 2016.

Only 0.9% of gabapentin prescriptions were prescribed for an FDA-approved diagnosis, while approximately 4% of pregabalin prescriptions were prescribed for an FDA-approved diagnosis.

In terms of prescription payments among workers’ comp claims, gabapentinoids are the third highest therapeutic group of drugs, behind dermatologicals and NSAIDs. In Q1 of 2020, 10% of prescription payments were for gabapentinoids in the median of the 28 study states.

Wide interstate variation in the dispensing of gabapentinoids was also observed. In Louisiana, Massachusetts, and New York, 10% of injured workers who received medication received gabapentinoids, but in California, Kansas, Missouri, and New Jersey, that number only reached 3%.

Concomitant prescribing of opioids and gabapentinoids – a dangerous combination that can cause serious breathing problems and other concerns – was seen. Nearly half of workers with gabapentinoid prescriptions received an opioid prescription in Iowa, Kansas, Louisiana, and Texas. This concomitant use rate was 20% lower in California and Nevada. This potent drug combination is concerning as the FDA published a warning in 2019 that serious breathing difficulties can occur in patients with respiratory risk factors taking gabapentin or pregabalin. Risk factors include the use of CNS depressants (opioids), respiratory conditions (COPD, sleep apnea), and advanced age.

In the past, Healthe has noted the shift from opioids to other medications for the treatment of pain, and in regards to gabapentinoids – as with any medication – there are inherent risks to consider.

Gabapentinoids can lead to mood alterations, suicidal thoughts, the potential for abuse, overdose, and breathing difficulties, which are more severe for older populations.

While recommended by some pain management guidelines as an appropriate treatment option in certain injured worker patient populations, gabapentinoids can have serious side effects including mood alterations, suicidal thoughts, the potential for abuse, overdose, and breathing difficulties, which are more severe for older populations.

Gabapentinoid users were found to be at:

  • 26% higher risk for suicidal behavior or suicide
  • 24% higher risk for overdose
  • 22% higher risk for head or body injuries

In 2017, the state of Ohio alone saw 426 million solid oral doses of gabapentinoids dispensed to patients.


Tags: gabapentinoids, WCRI, gabapentin, pregabalin, Lyrica


White House Issues Vaccine Mandate

President Biden issued a mandate that requires all federal employees – including members of the U.S. military, long-term care workers who serve Medicare and Medicaid enrollees, and federal contractors – to receive a COVID-19 vaccine, revoking their ability to receive regular COVID-19 tests as an alternative to vaccination.

This is part of a six-part plan to combat the COVID-19 pandemic in the face of rising cases due to the Delta variant.

The President also directed the Labor Department to draft new emergency rules requiring businesses with 100 or more employees to ensure all workers are either vaccinated or tested for COVID-19 once a week. Companies that do not comply would face thousands of dollars in fines per employee.

Prior to this proclamation, the uptick in COVID-19 cases has pushed vaccine mandates. Already there was a long list of local governments, businesses, and other organizations requiring employees to receive a COVID-19 vaccine, especially after the FDA approved the Pfizer COVID-19 vaccine.

Before the White House issued their mandate, some form of vaccine mandates have been enacted by the following organizations and/or jurisdictions:

  • Certain employees of Delta Airlines, United Airlines, CVS, Goldman Sachs, Chevron, the Walt Disney Company, McDonalds, Facebook, Google, NBCUniversal, Microsoft and more
  • Employees of city governments in Seattle, Portland, Tampa, Chicago, Los Angeles, and other major cities
  • Healthcare workers in Connecticut and New Jersey
  • Teachers in New York City

Tags: Vaccine, mandate, COVID-19, White House


Connect with Healthe at the 2021 National Comp Conference

The National Comp Conference – formerly known as the National Workers’ Compensation and Disability Conference (NWCDC) – will be held from October 20-22 in Las Vegas, offering in-person and digital events and educational sessions.

Here are three ways you can connect with Healthe!

A Session on Infectious Disease Safety in the Workplace

Among the presentations, our VP of Clinical Services, Silvia Sacalis, PharmD, BS, will cohost The New Rules of Infectious Disease Post-Pandemic: Adapt, Be Ready, Be Resilient.

Dr. Sacalis will be joined by Ceil Jung, RN, BSN, CCM, Director of Medical Services at SFM Mutual Insurance company, and the presentation will explore workplace strategies that protect the physical, mental, and social health of employees amid and beyond the pandemic. It also will include considerations for claims staff and injured workers regarding COVID-19 education.

This presentation is CME certified and will take place on Wednesday, October 20th at 11:00 AM

Take Part in Our Industry Insights Survey

Healthe will also partner once again with Risk & Insurance® to conduct our annual Workers’ Comp Industry Insights Survey. Our focus this year? Resilience in a post-pandemic industry. Workers’ comp professionals are invited to visit Healthesystems at booth #830, or Risk & Insurance at booth #822 , to answer questions and engage in discussion with Risk & Insurance editors. Upon completion of the analysis and results, Healthe will publish our annual industry insights survey in early 2022.

Get the Latest RxInformer

Visit Healthe at booth #830 to pick up the new Winter 2021/2022 edition of RxInformer journal. This edition focuses on the ripple effects of the pandemic, including:

  • Long-haul COVID-19 cases
  • Employer strategies for addressing infectious disease
  • How the pandemic has disproportionately impacted women in the job market
  • Issues of worker classification and benefit entitlement
  • And more

Can’t make it to our booth? Visit RxInformer online for the new issue!


Tags: Healthesystems, NWCDC, National Comp Conference, Risk & Insurance, survey, Industry Insights, conference, educational session