Employers expect to boost virtual care offerings

• Large employers expect to pay more than $15,500 per employee for health coverage next year, 5.3% higher than the $14,769 expected this year, according to an annual survey from nonprofit Business Group on Health. That’s slightly up from the 5% increase employers estimated in each of the previous five years. 
• Employers are increasingly welcoming virtual care options. About 80% of respondents said they believe telehealth will play a significant role in how care is delivered in the future, compared with 64% in 2019 and 52% in 2018. More than half said they will offer more virtual care to employees next year.
• Employers also plan to expand access to virtual mental health and emotional well-being services. More than 90% said they will offer telemental health services, and 54% plan to lower or waive those costs in 2021.

Six months into the pandemic, insurance companies are reporting record profits as Americans continue delaying routine in-person care. Many have turned to telehealth services or stopped receiving preventive and elective care altogether, making the exact cost employers will pay for workers’ health coverage “a moving target” over the next few years, Ellen Kelsay, president and CEO of the group, said.

While exact costs remain unclear, “you can look no further than a pandemic to very clearly see that matters of health and well-being do directly impact employee productivity, engagement and, moreover, how employers think about deploying their workforce,” Kelsay said Tuesday during a call with reporters.

Business Group on Health’s annual survey asked large employers about their healthcare strategies, with 122 businesses participating this year, representing a wide range of industries. The amount of employers who view their healthcare strategy as an integral part of their approach to their workforce increased from 36% in 2019 to 45% this year.

Beyond expanding online mental health resources, respondents also mentioned interest in virtual care for musculoskeletal management conditions. Musculoskeletal conditions were most frequently cited by employers as contributing to rising health care costs, and 29% of those surveyed said they will offer musculoskeletal management virtually next year.

Kelsay said virtual treatments for common joint conditions can help stave off unnecessary surgical interventions, and “now that we have a workforce that for many months has been working at home and probably not in the most ideal of ergonomic situations, we expect to see musculoskeletal conditions continue to worsen.”

Despite a pandemic, employers are still looking at their in-person care delivery sites as well. About 72% said they either have a clinic in place or will by 2023. And 34% offer primary care services at the worksite, while another 26% plan to have the service available by 2023.

There’s also interest in updating primary care strategies to focus on whole-person care. More than half said they’ll have at least one advanced primary care strategy, compared with 46% in 2020.

https://www.healthcaredive.com/news/virtual-care-driving-employer-health-costs-up/583711/

Cleveland Clinic, Aetna team up on insurance plan, ACO

• The Cleveland Clinic and CVS-owned insurer Aetna are forming an accountable care organization and launching a co-branded health insurance plan for employers in northeast Ohio, the organizations announced Wednesday.
• A nationwide part of the initiative will offer Aetna commercial plan members access to virtual second opinion services from Cleveland Clinic providers. They are also creating a Cardiac Center of Excellence program for plan sponsors nationwide. Employers often turn to COEs to control healthcare costs by incentivizing workers to go to a particular high-quality facility.
• The plans will be available to certain fully and self-insured employers in several Ohio counties beginning this fall. The companies estimate employers could save up to 10% in healthcare spending over typical plans. Cleveland Clinic will receive rewards for meeting quality and cost goals.

With the U.S. in a COVID-19 pandemic-caused recession, employers are especially worried about costs — and healthcare spending is notoriously a major concern.

A survey the Business Group on Health published this week found large employers expect their spending on employee health coverage to increase by 5.3% next year, a slight uptick from the increases they’ve estimated for each of the previous five years.

“Given the current economic climate, employers are looking for a cost-effective, high quality insurance plan that also provides access for their employees to coordinated care and advanced medical expertise,” Cleveland Clinic CFO Steven Glass said in a statement.

This isn’t the first time Aetna has partnered with a nonprofit health system. It formed a joint venture with Banner Health in 2017 to offer plans in Arizona. That plan recently began offering 98point6’s virtual primary care options.

Aetna also runs Haven Healthcare plans for J.P. Morgan Chase and Amazon employees that offer financial awards for wellness activities, and don’t have deductibles.

Cleveland Clinic has 18 hospitals, with 13 in northeast Ohio, and more than 200 outpatient facilities. With $11 billion in revenue and nearly a year’s worth of cash on hand, the nonprofit system is better positioned than some to weather the coronavirus crisis that has battered hospital finances.

CVS, like other commercial payers, posted a major profit increase in the second quarter of this year, although experts warn those conditions may not last as patients seek deferred care. CVS completed its acquisition of Aetna in November 2018.

The organizations could eventually look to expand the insurance plan beyond Ohio. Aetna has more than 22 million medical members across about 40 states. Cleveland Clinic has five hospitals in Florida, but could also expand telehealth services, which have become more popular during the pandemic.

Unlike integrated nonprofit systems such as Kaiser Permanente, Providence, UPMC and Intermountain Healthcare, Cleveland Clinic does not have its own health insurance arm.

https://www.healthcaredive.com/news/cleveland-clinic-aetna-team-up-on-insurance-plan-aco/583785/

New Guidelines Recommend Topicals for Musculoskeletal Injuries

Opioids don’t belong on the menu for managing acute pain from non–low back musculoskeletal injuries, except in cases of severe injury or when first-line therapies don’t work, according to new guidance from the American College of Physicians (ACP) and the American Academy of Family Physicians (AAFP).

“Opioid therapies are associated with little to no benefit in this population, but with substantial harms, such as potential for longer term addiction and overdose,” said Amir Qaseem, MD, vice president of clinical policy and the Center for Evidence Reviews at ACP in Philadelphia and lead author of the guideline, which is published online in Annals of Internal Medicine.

In addition to advising clinicians to avoid opioids, including tramadol, in most situations, the guideline recommends the following interventions for these patients.

• Treatment with topical nonsteroidal anti-inflammatory drugs (NSAIDs) with or without menthol gel as first-line therapy for symptom and pain relief and to improve physical function and patient satisfaction with treatment
• Treatment with oral NSAIDs
• Treatment with specific acupressure alone or with transcutaneous electrical nerve stimulation (TENS)

“We found that topical NSAIDs with or without menthol gel are most effective and associated with pain reduction, symptom reduction, improvement in physical function, and better patient satisfaction,” Qaseem said in an interview with Medscape Medical News. Although oral NSAIDs also reduce pain and relieve symptoms, “it is important to keep the harms associated with oral NSAIDs in mind, such as GI adverse events,” he stressed. Acetaminophen is an option for patients with gastrointestinal (GI) or renal risk factors.

With respect to nonpharmacologic interventions, acupressure and TENS have been shown to effectively reduce pain, Qaseem said.

The recommendations are based on a systematic review of the comparative safety and efficacy of drug and nondrug management of acute pain lasting less than 4 weeks. The review included 207 trials that enrolled 32,959 participants and evaluated 45 treatments. Nearly half of the trials (48%) enrolled patients with a variety of musculoskeletal injuries; 29%, patients with sprains; 6%, patients with whiplash; 5%, patients with muscle strains; and the remainder, patients with a variety of injuries, including nonsurgical fractures and contusions. The median patient age among all participants was 34 years (interquartile range, 28 to 39 years). The outcomes evaluated included pain (at ≤2 hours and at 1 to 7 days), physical function, symptom relief, treatment satisfaction, and adverse events. The guideline committee only recommended interventions that resulted in improvements in at least two of these outcomes.

The authors also considered a second systematic review that included data from 14 cohort studies looking at predictors of prolonged opioid use. The studies enrolled patients with work injuries, ankle sprains, low back pain, or other sources of musculoskeletal pain.

Topical NSAIDs Lead the Pack

Of the various management options, topical NSAIDs were the only intervention that improved all outcomes, the authors report. “They were among the most effective interventions for treatment satisfaction (high-certainty evidence) and for pain reduction at less than 2 hours and at 1 to 7 days; function; and symptom relief,” the guideline authors write. Further, the treatment did not increase patients’ risk for adverse effects.

Topical NSAIDs plus menthol gel also improved pain at less than 2 hours and relieved symptoms, although no evidence suggested that the combination provides additional benefit over topical NSAIDs alone. Even so, because the combination is unlikely to increase harm, “offering the combination therapy as another treatment option is reasonable,” according to the authors.

Several interventions improved only one outcome and as such did not meet recommendation criteria. These included massage therapy, acetaminophen plus ibuprofen plus codeine, and transbuccal fentanyl, all of which were linked to reduced pain at less than 2 hours; acetaminophen plus chlorzoxazone and ibuprofen plus cyclobenzaprine, which were associated with low-certainty evidence for pain improvement at 1 to 7 days; and laser therapy, which was associated with symptom relief.

With respect to the recommendation against opioid therapy, only one of five interventions showed improvements in more than one outcome. “High-certainty evidence showed that acetaminophen plus opioids reduced pain at 1 to 7 days and improved symptom relief; it also reduced pain at less than 2 hours, but this effect was small and not clinically important,” the authors write. In addition to large increased risks for neurologic and GI adverse effects, many patients prescribed opioids continued long-term use, they note.

The guideline committee members concluded that the potential harms associated with opioid use outweighed the benefits, noting that both longer prescribing periods (>7 days vs 1 to 3 days) and higher daily morphine milligram equivalents were predictors of prolonged use. “Combination therapies with opioids also cost more than similar interventions without opioids, and many effective nonopioid alternatives exist for the management of acute pain,” they write.

The recommendations against opioid use is a departure from recently published guidelines for pain management in acute musculoskeletal injury published by the Orthopaedic Trauma Association (OTA) Musculoskeletal Pain Task Force, which don’t address the use of topical NSAIDs. However, regarding opioids, this task force recommended the “lowest effective immediate release opioid dose for the shortest period possible.”

Opioids are commonly used to treat severe pain, but there is little evidence on their use in the short-term setting for acute injury, according to Joseph R. Hsu, MD, who was lead author of the OTA guidelines. As noted in the ACP guideline, some circumstances warrant opioid use in this population, but because of the potential for misuse, “the lowest dose for the shortest period should always be the approach,” said Hsu, from the Department of Orthopaedic Surgery, Atrium Health Musculoskeletal Institute, Charlotte, North Carolina. The OTA guidelines include specific recommendations for limiting opioid prescribing risks, such as adherence with state and local drug monitoring programs and opioid education for patients and providers.

The most effective pain management strategies are often multimodal, Hsu stressed. In addition to drug treatment, psychosocial interventions can reduce anxiety and improve pain coping, and physical strategies, such as massage and TENS, can reduce pain and symptoms, he noted.

According to Qaseem, the new ACP guideline is the first issued by the organization on this topic. “We expect the recommendations will be highly informative [to providers], from the benefits of topical NSAIDs to highlighting issues around opioids.”

The evidence reviews for the ACP/AAFP guideline were conducted by McMaster University and funded by the National Safety Council. Dr Hsu reports no conflicts.

Ann Intern Med. Published online August 18, 2020. Guideline full text, Systematic review (management of acute pain) abstract, Systematic review (prolonged opioid use) abstract

https://www.medscape.com/viewarticle/936027#vp_1

Axsome completes pre-NDA meeting for AXS-07

Axsome Therapeutics (NASDAQ:AXSM) has completed a successful pre-New Drug Application (NDA) meeting with the FDA for AXS-07 for the acute treatment of migraine.

The purpose of the meeting was to reach an agreement with the Agency on the proposed content and format of the Company’s NDA submission including the clinical and nonclinical requirements.

The company remains on track to submit the planned NDA in Q4.

https://seekingalpha.com/news/3607409-axsome-completes-pre-nda-meeting-for-axsminus-07

OpGen up on launch of COVID-19 test in Europe

Nano cap OpGen (NASDAQ:OPGN) rallies 53% premarket on robust volume in reaction to its announcement that subsidiary Curetis GmbH has received CE Mark certification for its SARS-CoV-2 molecular test with PCR-compatible universal lysis buffer (PULB).

The test uses real-time polymerase chain reaction (RT-PCR) technology for the qualitative (yes/no answer) detection of the coronavirus in oropharyngeal and nasopharyngeal samples.

Commercial launch is underway.

https://seekingalpha.com/news/3607391-opgen-up-53-on-launch-of-covidminus-19-test-in-europe

Kazia Therapeutics up on U.S. accelerated review tag for lead drug

Nano cap Kazia Therapeutics Limited (NASDAQ:KZIA) jumps 21% premarket on robust volume in reaction to Fast Track status in the U.S. for lead drug paxalisib for a type of brain cancer called glioblastoma.

Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.

Shares rallied in April when it reported positive preliminary data from a mid-stage study. Additional data should be available this year with final results expected in H1 2021.

Paxalisib, in-licensed from Roche in 2016, modulates an intracellular pathway called PI3K that plays a key role in cell growth, proliferation, survival and angiogenesis (growth of blood vessels).

https://seekingalpha.com/news/3607382-kazia-therapeutics-up-21-on-u-s-accelerated-review-tag-for-lead-drug

As U.S. schools reopen, concerns grow that kids spread coronavirus

U.S. students are returning to school in person and online in the middle of a pandemic, and the stakes for educators and families are rising in the face of emerging research that shows children could be a risk for spreading the new coronavirus.

Several large studies have shown that the vast majority of children who contract COVID-19, the disease caused by the virus, have milder illness than adults. And early reports did not find strong evidence of children as major contributors to the deadly virus that has killed more than 780,000 people globally.

But more recent studies are starting to show how contagious infected children, even those with no symptoms, might be.

“Contrary to what we believed, based on the epidemiological data, kids are not spared from this pandemic,” said Dr. Alessio Fasano, director of the Mucosal Immunology and Biology Research Center at Massachusetts General Hospital and author of a new study.

Schools across the country are trying out a wide range of strategies to reopen, from all online classes to all in person. They are asking whether reopening schools with stringent mitigation measures is worth the risk to students, families and educators, given that keeping schools closed will likely harm academic progress, social and emotional development, mental health and food security.

Dr. Fasano and colleagues at Boston’s Massachusetts General and MassGeneral Hospital for Children found that infected children have a significantly higher level of virus in their airways than adults hospitalized in intensive care units for COVID-19 treatment. The high viral levels were found in infants through young adults, although most of the participants were age 11 to 17.

The study, published on Thursday in the Journal of Pediatrics, involved 192 participants ages 0-22 who were seen at urgent care clinics for suspected COVID-19. Forty-nine of them – a quarter of the total – tested positive for the virus. Another 18 were included in the study after being diagnosed with multisystem inflammatory syndrome, a serious COVID-related illness than can develop several weeks after an infection.

The research suggests that children can carry a high viral load, meaning they can be very contagious, regardless of their susceptibility to developing a COVID-19 illness.

“There has been some conflicting data out there about the degree to which children can be contagious,” said Dr. Marybeth Sexton, assistant professor of infectious diseases at Emory University School of Medicine in Atlanta, who was not involved in the study. “This is further evidence that we may see children as sources of infection.”

She added more extensive research is needed.

“NOBODY IS SPARED”

A separate study published last month in JAMA Pediatrics found that older children hospitalized with COVID-19 had similar levels of the virus in their upper respiratory tract as adults, but children younger than five carried significantly greater amounts.

However, other medical groups show differing information over children’s potential to spread the virus. The American Academy of Pediatrics on Wednesday updated its guidelines to reflect “that children under 10 years may be less likely to become infected and spread infection, while those 10 years and older may spread it as efficiently as adults.”

A recent South Korean study found that people were most likely to contract the new coronavirus from members of their own households, with children aged nine and under least likely to be the first identified case.

Since most children infected with the coronavirus have very mild symptoms, they were largely overlooked as a demographic in the earlier stages of the pandemic, Dr. Fasano said.

The U.S. Centers for Disease Control and Prevention reported a pediatric COVID-19 hospitalization rate of 8 per 100,000 for March 1 to July 25, compared with a rate of 164.5 per 100,000 for adults.

Experts say the incidence of a related issue, which can develop after COVID-19 infection, multisystem inflammatory syndrome, is concerning. “The number of these patients is growing,” Dr. Fasano added.

Concerns have also been raised about cases of type 1 diabetes among children diagnosed with COVID-19. A small UK study found that the rate of diabetes almost doubled during the peak of Britain’s COVID-19 epidemic, suggesting a possible link between the two diseases that needs more investigation.

“The more we understand, the more it boils down to nobody is spared in this pandemic,” Dr. Fasano said.

https://www.reuters.com/article/us-health-coronavirus-children/as-u-s-schools-reopen-concerns-grow-that-kids-spread-coronavirus-idUSKCN25G0CS