Healthcare Pandemic Roundup
The global outbreak of the SARS-CoV-2 virus has profoundly affected healthcare. This blog tracks technology developments, business trends, and regulatory updates that impact healthcare ecosystem stakeholders including startups, providers, investors, and more.
Healthcare Innovation During the Pandemic
- Innovation has taken many forms during the Covid-19 pandemic to date, including new telehealth models, prefabricated and online-only hospitals, drone deliveries of supplies, lung-imaging stethoscopes used at home, and drug development partnerships between competitors (World Economic Forum, 11/25)
- The BioNTech/Pfizer and Moderna vaccines are the first to use messenger ribonucleic acid (mRNA) which triggers an immune response by teaching our cells how to make a protein or a piece of a protein rather than injecting the virus itself (Medical News Today, 12/15)
- The pandemic has accelerated the adoption of telehealth, and some providers are optimistic about the continued part telehealth can play to increase access, safety, and health outcomes (Harvard Business Review, 12/11)
- Both public and private-sector contributions were important in Covid-19 vaccine development, mirroring earlier technological breakthroughs with broad societal impact (New York Times, 12/15). Years of government-funded (and sometimes government-conducted) research into viral proteins and genetics was “the essential ingredient in the rapid development of vaccines in response to Covid-19” (Kaiser Health News, 11/18). Governments across the globe spent tens of billions of dollars on research and paid drug companies to manufacture hundreds of millions of doses before the vaccines were approved for distribution (The Atlantic, 12/15)
- The FDA gave Emergency Use Authorization to BioNTech and Pfizer’s Covid-19 vaccine on December 11 (MedCityNews, 12/11) and Moderna’s on December 18 (Nature, 12/18); there remain over a dozen other vaccines in late stages of development (New York Times, 12/17). The Moderna vaccine has shown evidence of being more effective at preventing severe cases in its clinical trials (LA Times, 12/15)
- Years after first grabbing headlines, digital therapeutics are coming to market. Covid-19 has accelerated the demand for digital and remote care, and digital therapeutics are garnering more attention (MedCityNews, 12/12)
- The CDC expects the 21 million health care personnel to be among the first Americans to get the vaccine (CDC, 12/1), and as the first doses are rolling in, different healthcare systems are following different internal distribution protocols (Kaiser Health News, 12/14)
- Even as patients returned to in-person outpatient visits, telehealth usage remained well above the pre-pandemic levels, indicating that telehealth could remain an important way healthcare is delivered (Commonwealth Fund, 10/15)
- Medicaid made telehealth more widely available to patients during the pandemic because it was declared a Public Health Emergency (PHE); unfortunately, both broader patient eligibility and coverage of telehealth services are expected to shrink when the Department of Health and Human Services declares the PHE over. (Manatt, 12/14)
- Mental health is the top telehealth diagnosis in the US, representing just over 50% of all diagnoses in September (FAIR Health, 12/1)
- Those without prior symptoms of depression and anxiety have been affected just as severely by the pandemic as patients with existing diagnoses (The Lancet Psychiatry, 12/8)
- In a longitudinal cohort study of almost 1.5 million Swedish youth, young adults who suffered from depression as children exhibited higher rates of other diseases and disorders (JAMA Psychiatry, 12/9)
- Covid-19 has exacerbated an existing mental health crisis in the United States, but policymakers have an array of technological and social interventions available such as universal mental health screenings and digital tool adoption (Health Affairs Blog, 12/14)
Week of September 7, 2020
Spotlight on Children’s Health
The CEO of the Children’s Hospital Association recently wrote: “It may be years before we understand the true toll of the Covid-19 crisis…for kids” (US News, 6/4). As the country wrestles with how children should return to school, we know that even healthy children have been affected emotionally, socially, and developmentally during this pandemic.
Healthcare for Kids
Following stay-at-home orders this spring, doctors saw significantly fewer patients. A study across all age groups in the US shows a 60% overall drop in care by late April (Commonwealth Fund, 8/13). Pediatric office visits, immunizations, and procedures dropped 36% at Colorado Children’s and 74% in primary care offices affiliated with the Children’s Hospital of Philadelphia (US News, 6/1 & 6/8), with similar ranges at other US pediatric hospitals according to the Children’s Hospital Association (US News, 6/4).
The rise in telehealth has not compensated for the decline in office visits and procedures: telehealth offset only 7–16% of the drop in total visits across all age groups, including children (Commonwealth Fund, 8/13). This is despite a significant increase in telehealth visits at some providers like the Children’s Hospital of Philadelphia, which saw an increase from 10 to 1,900 telehealth visits daily (US News, 6/8).
Pediatric visit rates in the US have been substantially lower than the baseline compared with adult visits throughout the pandemic:
As of the end of July, pediatric visit rates remain 26% below baseline, the second-highest decline of all specialties studied (Commonwealth Fund, 8/13).
Unsurprisingly, fewer children have received vaccinations. In the US, 3 million fewer routine pediatric immunizations were administered from January to April 2020 compared to the same period a year prior (CDC, 5/15). Globally, approximately 80 million children under the age of 1 in at least 68 countries could miss out on potentially life-saving vaccines due to lockdowns, according to the WHO, UNICEF, Gavi, and the Sabin Vaccine Institute (UNICEF, 7/2020).
What happens when kids receive less healthcare? There are few studies, but one recently published by Johns Hopkins researchers notes a potential increase in indirect child mortality of additional 250,000 to 1.2 million children due to Covid-19 (The Lancet, 5/12).
Covid-19 in Children
Children represented 9.3% of the known Covid-19 cases in the US, at a rate of 583 cases per 100,000 as of mid-August (Children’s Hospital Association & American Academy of Pediatrics, 8/20). This figure doubled during the six weeks from July 9 to August 13, totaling 406,109 cases reported from 49 states (Wall Street Journal, 8/24). A study published in Nature Medicine across 6 countries projects that children are only half as likely to become infected by SARS-CoV-2 as adults. The same study suggests that only 21% of infected children ages 10–19 show symptoms, compared with 69% over the age of 70 (Washington Post, 6/16).
However, researchers have evidence that children can transmit the SARS-CoV-2 virus, which causes Covid-19. Some studies cite that infected children carry similar levels of the virus as adults whether or not they show symptoms, and a recent study showed that some children under the age of 5 carried 10 to 100 times of the viral RNA as adults in their upper respiratory tracts (JAMA, 7/30). Consistent with other studies, some researchers in South Korea believe that children under the age of 10 may be half as likely to transmit the virus (New York Times, 7/18), although the researchers said the findings may have been skewed by small sample size and asymptomatic cases (Wall Street Journal, 8/9). The same study found that older children aged 10 to 19 are as likely as adults to spread the virus (New York Times, 7/18). “It’s not true to say that they do not transmit,” said Bill Hanage, an epidemiologist at the Harvard T.H. Chan School of Public Health (New York Times, 8/14).
Children can be hospitalized and can die from Covid-19, but the rate is significantly lower than adults according to the CDC, which published a study of both rates by age group:
As of early August, there have been 90 child deaths from Covid-19 in the US; for comparison, there are roughly around 100 pediatric deaths from influenza every year (CNN, 8/11).
Covid-19 and MIS-C
Children who are infected by SARS-CoV-2, the virus that causes Covid-19, can develop multi-inflammatory syndrome (MIS-C), a rare but severe condition involving features of shock, with cardiac involvement, gastrointestinal symptoms, and significantly elevated markers of inflammation (CDC, 8/14). The New England Journal of Medicine recently published two studies on MIS-C from researchers at Boston Children’s (NEJM, 6/29) and the New York State Department of Health (NEJM, 6/29), showing a low incidence rate and severe symptoms.
In an editorial in the New England Journal of Medicine, Michael Levin of the department of infectious diseases at Imperial College London cited that roughly 1,000 cases of MIS-C had been reported worldwide by the time of publication. (NEJM, 6/29), and since, the CDC has confirmed 692 cases in the US (CDC, 8/20). Levin writes, “The disorder is uncommon — occurring in just 2 in 100,000 people aged younger than 21 years. The rate of SARS-CoV-2 infection in the same age group is 322 per 100,000” (Healio, 6/29). Yet Levin also expressed concern that “children meeting current diagnostic criteria for MIS-C are the ‘tip of the iceberg,’ and a bigger problem may be lurking below the waterline” (StatNews, 6/29).
Mental Health and Social Development
Mental health across all age groups has been impacted during the pandemic. A study based on the 2016 National Survey of Children’s Health indicated in the US, 7.7 million children aged 6–17 were diagnosed with at least one mental health issue and 49.4% of children were untreated (JAMA Pediatrics, 2/2019). Since the pandemic spread, a study published in JAMA Pediatrics of 2,330 schoolchildren in China’s Hubei province noted that 22.6% of students reported depressive symptoms and 18.9% were experiencing anxiety after an average lockdown of 33.7 days (Time, 7/23).
Fortunately, virtual mental care has become more accessible in the US due to actions by the FDA and CMS, The Centers for Medicare & Medicaid Services. In April, the FDA relaxed restrictions on digital behavioral health applications (FDA, 4/14), and CMS temporarily expanded reimbursement for the types of telehealth providers can offer. This has led to the doubling of demand for video visits at some mental health companies (Fierce Healthcare, 7/28). Adolescents might benefit: Gen Z is the second most open to engaging with virtual mental health services after Millennials (Accenture, 7/20). Still, some concerns remain about the lack of evidence-based medicine in digital mental health platforms: because mental health symptoms are not routinely measured, it is difficult to collect evidence on whether a treatment actually works (MobiHealth News, 8/14).
Access to Education
Mental and emotional wellbeing and development are reasons often cited for the need for children to return to school. However, there is no consistent agreement on whether or how children should return. The American Academy of Pediatrics recommended students return to school this fall, at odds with some public health officials. AAP cites the benefits of live education on learning, social and emotional development, mental and physical health, nutrition, and the critical role schools play in addressing social and racial inequity. In its statement, the AAP states that “children may be less likely to become infected and to spread infection” (American Academy of Pediatrics, 8/19). In contrast, another analysis based on guidelines from Harvard and the WHO found that most schools across the country should remain partially or completely closed based on the number of cases and testing availability at a county level (New York Times, 8/14).
To date, 188 countries have imposed school closures, affecting more than 1.5 billion children and youth. (UN Policy Brief: The Impact of Covid-19 on Children, 4/16). In the US, low-income students are likely to receive diminished instruction during the pandemic due to school district resources, home environments, and lack of access to technology (McKinsey, 6/1).
Social Determinants of Health
With an economic crisis accompanying the health crisis, it has become more difficult for many who have lost their jobs or income to keep health insurance and pay for care. In Florida alone, over 58,000 children are expected to move from the State Children’s Health Insurance Program to Medicaid as family incomes drop (CBS Miami, 8/20). Prior to the pandemic, Medicaid was already the payor for over 50% of patient volumes for most pediatric hospitals nationally (US News, 6/4).
Prior research has established a link between parents’ unemployment and kids’ mental health: in a 2018 paper published in Health Economics, researchers found a 5% increase in the national unemployment rate correlated with a 35% to 50% increase in “clinically meaningful childhood mental-health problems” during the Great Recession of 2007–2009 (Time, 7/23).
Globally, the ongoing crisis could add another 117 million children to the current 584 million children living in monetarily poor households by the end of 2020 (UNICEF, 6/2020). A rise in poverty and could lead to an increase in child labor in certain countries: UNICEF calculates that a 1% rise in poverty could lead to at least a 0.7% increase in child labor in certain countries. “This is a universal crisis and, for some children, the impact will be lifelong” (UNICEF, 8/2020).
Week of August 24 — Other News
- As schools consider re-opening, temperature checks remain an imperfect proxy for diagnosing Covid-19. Dr. Anthony Fauci advised against using them as a public health measure, as everything from a sweaty brow to ibuprofen can interfere with accuracy (ABC7 NY, 8/13)
- Using contact tracing as a tool to identify high-risk patients, a public health team was able to reduce death rates by deploying pulse oximeters to monitor vulnerable patients who may have been exposed in the White Mountain Apache Tribe (New York Times, 8/13)
- Researchers do not know why some people experience more severe symptoms of Covid-19 than others, nor do we know much about immunity: “We don’t know for how long that immune response lasts. We don’t know how strong it is” notes WHO’s Van Kerkhove (STAT, 8/17)
- Most vaccines take 10–15 years to develop, and the fastest vaccine ever created took four years. Pharma companies are expediting the timeline by running multiple phases concurrently and increasing manufacturing capabilities before drugs are approved (CNN, 8/14)
- The head of the World Health Organization advised against “vaccine nationalism,” highlighting that the global nature of this pandemic merits an internationally coordinated response (NPR, 8/18)
- With government incentives, pharmaceutical companies who would normally compete are collaborating to develop Covid-19 treatments and vaccines (Bloomberg, 8/24)
- Health systems are facing a backlog of care now that elective procedures are once again being sought by patients. Healthcare providers should consider equitable procedure prioritization as they work through the operational challenges in delivering care quickly (Harvard Business Review, 8/10)
- In a shift brought on by the pandemic, providers are evaluating remote work as a long-term option for staff in IT, revenue cycle management, and other administrative functions (Becker’s Health IT, 8/19)
Week of August 9, 2020
- While US testing rose from 550,000 to 820,000 daily tests last month, test results continue to be slow given supply chain issues. Admiral Brett Giroir, the assistant secretary for health, stated it’s not possible to get results in 48–72 hours given current supply and demand (New York Times, 7/31)
- Slow test results and lack of consistent guidance on behavior while waiting for results complicate virus containment (Kaiser Health News, 7/29)
- Slow test results are also compounding challenges faced by state and local contact-tracers, who are struggling to keep up with virus spread (New York Times, 7/31)
- Childhood vaccinations are increasing, but are still below pre-pandemic levels. In Florida, vaccines were down 25% in June compared to 2019, while in May, New York saw vaccine rates fall by as much as 91% (ABC News, 8/5)
Racial Disparities in Healthcare
- While children have been less severely affected, there are notable differences in the rates of infection and mortality between caucasian and non-caucasian pediatric patients (Pediatrics, 8/1)
- Doctors exhibit similar levels of implicit bias as the general population, compounding barriers to care facing underserved pediatric patients (Pediatrics, 8/1)
- Disproportionately impacted minority populations can be included in Covid-19 vaccine trials (Kaiser Health News, 7/27)
- 48% of Americans said they would get a Covid-19 vaccine as soon as one is available; respondents over 75 were the most eager to get a vaccine, while those who had not had a flu shot in the last 2 years were least eager to get a vaccine (Becker’s, 8/5)
- In July, the US government distributed another $4B to drug makers to produce a Covid-19 vaccine — J&J, Sanofi and GSK joined Pfizer, Moderna, and Novavax as the latest companies to receive funding, which now totals over $9B (New York Times, 7/31, MedCityNews, 8/7)
- Normally, the private sector purchases the majority of vaccines, but the government is taking this unusual approach to accelerate development, spur innovation, and ensure equal access to care (New York Times, 7/22)
- While many patients have delayed seeking care, hospitals can serve non-Covid-19 patients by implementing tactics like pooling — where hospitals collaborate to route and treat inpatients by specialty, for example, acute stroke care in one place, transplants in another, trauma in another, etc. (Harvard Business Review, 7/14)
- Outbreaks of Covid-19 in nursing homes have prompted innovations in remote care software and hardware to improve senior care at home (MedCityNews, 8/3)
Week of July 26, 2020
- Healthcare venture funding totaled $10.4B in the first half of 2020, the largest two back-to-back quarters on record, nearly matching the $10.7B invested in all of 2019 (Silicon Valley Bank, 7/23)
- Two digital health companies have gone public since July 1, following seven others over the past 14 months. Amwell, one of the largest telehealth providers, is planning an IPO for later this year (Rock Health, 7/20)
- Amidst conflicting claims of efficacy, the only two widely used and clinically-validated treatments for Covid-19 are ventilators and prone positioning. Many other solutions are in the pipeline, with Remdesivir and Dexamethasone showing promise (New York Times, 7/17)
- In an interview with Harvard Business School, Merck’s CEO highlighted that the fastest “truly new” vaccine ever brought to market took 4 years, and even once we have a vaccine there will be manufacturing and distribution challenges (Harvard Business School, 7/13)
- This month, the US government awarded Pfizer $1.95B to produce 600 million vaccine doses (100 million by year-end) (New York Times, 7/22) and $1.6B to Novavax for 100 million vaccine doses by early 2021, bringing the total to $5.75B to 7 Covid-19 vaccine projects (Quartz, 7/9). Since February, a total ~$7B of government funds have been awarded to vaccine projects and 48 other diagnostic, therapeutic, and other types of projects, including scaling the manufacture of glass (Quartz, 7/9)
- Pfizer and BioNTech vaccines recently received fast track designation for the FDA, as the race to develop treatments and preventives continues (CNBC, 7/13)
- Moderna reported successful Phase I trial results from a 45 person study on the safety of their mRNA vaccine. Phase I trials principally focus on safety, and no adverse events were reported, while all participants displayed immune responses (New England Journal of Medicine, 7/14)
- AstraZeneca and Oxford reported Phase I/II trial results about 1,000 adults generated an immune response (The Lancet, 7/20). Phase III trials in low-to-middle income countries including Brazil and South Africa which are already underway, and a Phase III trial in the US enrolling 30,000 patients and a pediatric study are next (University of Oxford, 7/20)
- To stay on top of the latest developments on treatments and vaccines, follow this Coronavirus Drugs and Treatments tracker (New York Times, 7/22)
- Representatives from five pharmaceutical companies who testified in Congress this week agreed there is an immediate need to begin to build public trust and acceptance in a vaccine (Medscape, 7/21)
- Many test results are communicated via fax machines, another complication slowing the Covid-19 testing system (New York Times, 7/13)
- On July 11th, New York City reported zero deaths from Covid-19 for the first time since early March (NBC, 7/12)
- As masks become a part of everyday life, companies are developing products that help with everything from speaking more clearly to sipping iced coffee without de-masking (Fast Company, 7/14)
- Patients often face long-term consequences after recovering from Covid-19, from respiratory issues to heart and kidney problems (Business Insider, 7/13)
- 5.4 million laid-off workers lost their health insurance from February to May, and in 8 states 20% or more of adults are now uninsured. This is the highest ever increase in the uninsured population, and this could nearly double by the end of 2020 to 10.1 million people according to the Robert Wood Johnson Foundation (Families USA, 7/13)
- The uninsured may not be able to afford COBRA premiums and may not know they qualify for Medicaid, as government funding for outreach programs has been cut (Families USA, 7/13)
Return to Work
- Many workers are looking forward to the routine and social elements of getting back to work (CNBC 7/13), an opportunity our colleagues analyzed in our Risky Business blog 8 Technologies for Returning to Work (7/2)
- In a partnership with Oakley, the NFL unveiled a mouth shield for helmets designed to combat the spread of Covid-19 on the field (ESPN 7/13)
Week of July 6, 2020
- Mirroring financial innovation after 2008, innovation in healthcare is accelerating in three areas: new applications powered by data, remote care, and unbundling care into narrow clinical areas (Forbes, 5/31)
- Despite the pandemic, total digital health venture capital deal value and volume in Q2 2020 remained stable (MobiHealthNews, 7/2). Total funding in the first half of this year rose nearly 20% from the same period a year ago (Startup Health, 7/1)
- Months into the pandemic, the US does not have adequate testing capacity to meet public health needs (New York Times, 7/6)
- Public health departments are struggling to do more with less: over the last 10+ years, state and local public health departments’ budgets have been cut by 15–20% and have 38,000+ fewer jobs (Kaiser Health News, 7/1)
- The US federal government has invested roughly $5B into 54 projects of Covid-19 related diagnostics, vaccines, therapeutics, and other areas. $3.8B of this funding went to 6 vaccine projects after Novavax received $1.6B on July 6 to deliver 100 million doses by early 2021 (Quartz, 7/9)
- Rural and minority communities are more severely affected by the pandemic, but digital health technologies could help serve these groups and provide accessible care (MedCity News, 6/30)
- Experts calculate that those who have succumbed to Covid-19 are dying an average of 10–14 years earlier than they would if they had not been infected, according to a study of Covid-19 fatalities (Quartz, 6/24)
- Drug rehab centers around the country are closing or limiting capacity because of Covid-19, even as the pandemic increases the need for addiction care (Kaiser Health News, 7/6)
- Virtual medicine is more than telehealth: connected medical devices and equipment can help provide more efficient and smarter care (MIT Tech Review, 6/29)
- 80 years ago, house calls made up as much as 40 percent of US doctor visits; today, telehealth, AI chatbots, and other technologies are helping doctors find their way back into the home (MedCity News, 7/6)
Return to Office
- Employers are grappling with whether and how to bring people into work safely, using solutions like continuous ultraviolet sterilization in elevators and plexiglass barriers (New York Times, 6/7)
- Our colleagues have analyzed technologies and solutions to enable a safe return to the office in our Risky Business blog: 8 Technologies for Returning to Work (7/2)
Week of June 22, 2020
- 20 states are seeing increasing infections as the US passes 2 million confirmed Covid-19 cases (NPR, 6/10)
- A mathematical model from Cambridge researchers found that if all individuals wear facemasks all the time, the rate of transmission could fall low enough to stop the spread of the pandemic (Proceedings of the Royal Society A, 6/10)
- Nearly half of all Americans either have, or know someone who has, delayed getting care since the beginning of the pandemic, as financial insecurity and lost health insurance benefits combine with fear of getting the virus (New York Times, 6/16)
- Even after surviving ICUs and ventilators, Covid-19 patients sometimes face a long road to recovery, battling mental and physical challenges (Washington Post, 6/9)
- The FDA revoked “Emergency Use Authorization” for Chloroquine Phosphate and Hydroxychloroquine Sulfate as treatments for Covid-19 due to mounting evidence that the drugs are not effective in treating Covid-19 (FDA, 6/15)
- After suspending or canceling over 300 trials, pharma companies are being forced to adopt virtual and decentralized approaches to running clinical trials (Business Insider, 6/11)
- Medical-grade glass vials are the latest pharmaceutical product to encounter short supply — vials are essential for storing doses of vaccines and other drugs (Wall Street Journal, 6/16)
- Even as pharma companies and hospitals develop more accurate antibody tests, the reliability of testing can vary dramatically based on the prevalence of Covid-19 within a community (Wall Street Journal, 6/10)
- As the US government awards contracts for domestic manufacturing of Covid-19 test components, supply chain quality-control issues have emerged with some of the new companies formed to meet testing demand (Wall Street Journal, 6/18)
- The first two Covid-19 vaccine candidates have begun Phase III trials, with over a hundred candidates in other phases of pre-clinical and clinical testing (New York Times, 6/10)
- An ideal vaccine prevents infection, but the FDA is also evaluating vaccines that prevent severe symptoms and reduce onward transmission (Bloomberg, 6/15)
- To reach to a “new normal”, patients must feel safe in healthcare facilities, and health systems around the country are responding (Becker’s Hospital Review, 6/5)
- Health systems are adapting to Covid-19 for the near and long term, including Geisinger, which applied innovation principles to craft a four-phase approach (Harvard Business Review, 6/11)
- HHS is distributing $15B to health systems that participate in state Medicaid and Children’s Health Insurance Programs (“CHIP”) and have not received a payment from the provider relief fund — payments to Medicaid and CHIP providers will be based on annual patient revenue, and the payment will be at least 2% of reported gross revenue from patient care (HHS, 6/9)
Week of June 8, 2020
- You might be surprised: Wastewater testing has shown early signs of promise as a complement to patient testing programs to monitor the spread of Covid-19 (Bloomberg, 6/1). This approach has been used in the past to monitor polio outbreaks.
- Maintaining an active lifestyle is important for mental health: researchers found that decreases in physical activity were correlated with increased symptoms of depression and anxiety by studying 3,052 US adults (Cambridge Open Engage, 5/5)
- As masks become everyday accessories, designers are reimagining form and function, inspiring people to want to wear them (Fast Company, 5/4)
- Harvard Health has a guide to help answer all your coronavirus questions (Harvard Health, 5/20)
- Estimates suggest that 60% of the population must be immune to achieve “herd immunity” which likely require vaccines; in the meantime, our health system is bracing for a prolonged pandemic and a potential second wave (JAMA, 5/22)
- Finances and managing elective procedures are the top two concerns of hospital systems, who anticipate a gradual return of elective procedure volumes to 80% by year-end 2020 even if there is a second wave (L.E.K., 5/21)
- Here is a projection on how Covid-19 could impact a health system’s margins over the longer term (McKinsey, 4/24)
- The first antibody therapy for Covid-19 entered the clinic in a Phase I trial, while several more are still under development (CNN, 6/2)
- Remote and digital clinical trials are experiencing rapid growth as in-person trials slow down due to Covid-19 (Crunchbase News, 5/20)
- A lack of national coordination between a fragmented system of labs and providers has kept testing levels below capacity (New York Times, 5/21)
- The Lancet and the New England Journal of Medicine retracted two studies on the use of malaria drug Hydroxychloroquine for the treatment of Covid-19, amid concerns about data accuracy (STAT News, 6/4). In related news, the first double-blind randomized, placebo-controlled study of Hydroxychloroquine found that the drug did not prevent patients from developing Covid-19 (New England Journal of Medicine, 6/3)
- With 100 vaccine projects underway, this helpful primer categorizes the different types under development (New York Times, 5/20)
- Manufacturing, distributing, and administering a vaccine at scale could be a bigger challenge than finding one (New York Times, 5/20)
- After confirming safety with a successful Phase I trial, Moderna’s mRNA entered a 600-person Phase II trial to establish efficacy. If approved, it would be the first mRNA vaccine for humans (National Geographic, 5/29). Moderna’s Phase III protocol was approved by the FDA, with the trial starting in July (Moderna Press Release, 6/11)
- Switzerland rolled out the first contact-tracing app based on Apple and Google’s combined technology platform (BBC, 5/26)
- For more on contact tracing apps, see our in-depth review in our post below
Week of May 18, 2020
Following last week’s quick reference guide to diagnostics, this week’s roundup includes context for recent vaccine and diagnostic announcements and exploration of contact tracing technology. Other highlights include the surprising impact of the pandemic on some healthcare providers, ramifications on mental health globally, and unprecedented collaboration across the healthcare industry.
Contact Tracing Apps
In conjunction with testing, contact tracing can be an effective way to limit the spread of Covid-19 according to the Harvard Center for Ethics, 4/3. Contact tracing smartphone apps work by tracking a person’s location, communicating with nearby devices via Bluetooth, and combining this information with a record of confirmed Covid-19 cases to predict exposure (Wall Street Journal, 5/12). If someone tests positive, the goal is to trace their movements, identify anyone they may have exposed, and to have those contacts self-isolate (Wall Street Journal, 5/12).
While smartphone apps are an appealing solution, they face some barriers to adoption. Epidemiologists estimate that contact tracing apps become useful with 60% population-level adoption (Economist, 5/16). While 81% of US adults have smartphones, the rate of smartphone ownership varies by demographic, and just 53% of those over 65 own such devices (Pew Research, 2/5/19). In developed economies globally, 75% of adults own smartphones, while just 45% of those in emerging economies people own smartphones (Pew Research, 2/5/19).
There are also privacy and cultural concerns that may slow the adoption and efficacy of digital contact tracing (Harvard Business Review, 4/15). While contact tracing smartphone apps have seen early success in East Asia, questions remain about how to implement them effectively elsewhere (Harvard Business Review, 4/15). Efforts are being made to encrypt personal data in contact tracing apps, but there is still work to be done to create a secure, interoperable system (Harvard Center for Ethics, 4/3).
Additionally, contacting people who may have been exposed can be difficult: years of robocalls have led people to ignore calls from numbers they don’t recognize, and certain demographics are wary of sharing personal information with public officials (MIT Technology Review, 5/16).
In sum, contact tracing tech solutions can suffer barriers to adoption due to access, privacy, cultural, and habitual patterns. It remains to be seen how broadly viable these solutions are, and how they can be adapted locally.
- Increased collaboration across the healthcare industry is helping spur real-time innovation, according to several healthcare industry leaders interviewed (Business Insider, 5/12). Pharma companies are sharing data on vaccines and treatments, providers have accelerated digitization and remote care, telehealth has expanded to Medicaid patients, and mail-order pharmacies have come to the fore.
- Even before the pandemic, the global economy lost more than $1 trillion annually from the effects of anxiety and depression. Due to added stressors arising from Covid-19, alcohol consumption is up and the prevalence of depressive disorder has as much as tripled in certain geographies. While certain populations are especially at risk, including healthcare workers, older adults, and children, this could also be an opportunity to increase access to mental healthcare in a way that lasts beyond the pandemic (UN Policy Brief, 5/13)
There are now two approved at-home sample collection kits for Covid-19:
- On May 8, the FDA extended the emergency use authorization to sell an at-home saliva test kit collected unsupervised by a patient showing symptoms. All other tests use a nasal swab, and at the time, were collected by a healthcare provider. Rutgers had 75,000 of the saliva test kits ready to ship and could process 20,000 tests each day, with a 48-hour turnaround at the time of writing (New York Times, 5/8)
- This week, the FDA issued the first emergency use authorization for an at-home sample collection kit that can then be sent to labs for Covid-19 testing (FDA, 5/16). The kit, made by digital health startup EverlyWell, joins a list of 75 other approved serological, antigen, and PCR tests (FDA)
- While Covid-19 has affected fewer children than adults, pediatric health systems are still financially impacted as elective procedures and surgeries are down by as much as 80% (San Francisco Chronicle, 5/16)
- As of May 11, there were over 100 candidate vaccine projects globally, according to the WHO, and nine candidate vaccines were being tested in clinical trials in humans (GAVI, May 11)
- Despite the recent positive press around vaccine development at Moderna, University of Oxford, and a consortium in China, scientists urge caution when interpreting small animal and human trial results, and offer useful considerations to understanding the studies’ limitations (Nature, May 19)
Week of May 11, 2020
In this week’s recap, highlights include the financial toll of the Covid-19 crisis on providers and payers, a potentially promising step toward testing at scale, and ongoing efforts to develop and distribute vaccines and treatments.
Outside of Covid-19 treatment, fewer patients are seeking care and more are uninsured: one study estimates patient visits dropped by more than half vs. 2019 and projects uninsured patients doubled over 90 days as unemployment rose. While provider financial losses mount, some health insurers are issuing rebates as premiums substantially exceed claims from fewer visits. Finally, the FDA approved a new antigen test, the first which could be routinely enough to monitor the population nationally, but challenges remain in the manufacturing and scale-up of therapies and vaccine candidates. Plus, we offer a quick reference guide for Covid-19 diagnostics and how they are used.
- The FDA issued its first emergency use authorization for a Covid-19 antigen test, a rapid, inexpensive diagnostic, which could scale to test millions of people per day. (FDA, 5/9) There are other types of diagnostic tests already available which we describe at the end of this post.
- The necessity of social distancing combined with the need to see patients has led to breakout growth for telehealth (JAMA, 5/1), accelerating virtual care adoption timelines ahead by as much as a decade per Kevin Fitzgerald, MD of the Mayo Clinic (Becker’s Hospital Review, 5/8)
- A detailed analysis by specialty and procedure of 2 million patient encounters across 40 states cites a 54.5% decrease in unique patient visits compared to the same period last year. Modeled against the entire US health system, this would result in a deficit of over $60B monthly and require an additional $300B in government relief (Strata Decision Technology, 5/11)
- In line with rising unemployment numbers, the percent of uninsured or self-pay patients in the United States could increase from 7→ 15% from January to May (Strata Decision Technology, 5/11)
- The Affordable Care Act limits the ratio of premium payment dollars that insurers can take as profits, and as insurers’ costs drop, they could pay out as much as $2.7B in rebates to members (Kaiser Family Foundation, 4/17). UnitedHealth Group just announced $1.5B in Covid-19 relief, some of which will come in the form of premium billing credits (UnitedHealth Group, 5/7)
- Even after successfully developing a vaccine, with global supply chain disruptions, it will be challenging to produce enough vaccines to immunize the US population (New York Times, 5/1)
- Drug repurposing may help speed the discovery of Covid-19 treatments, as finding a new application for a compound that has already been proven safe accelerates the pathway to the clinic (New York Times, 4/30)
Government and Regulatory
- The FDA eased the distribution of approved Covid-19 treatments and diagnostics, as well as products that meet emergency medical needs. The agency relaxed normal Drug Supply Chain Security Act (DSCSA) regulations that require product serialization and provenance data sharing for transactions (FDA, 4/30)
Diagnostic Quick-Reference Guide
There are different types of diagnostic tests and each category has its own unique role.
- PCR tests diagnose active Covid-19 cases and are highly specific, yet relatively slow and expensive. PCR (polymerase chain reaction) tests use a molecular technique to identify the genetic material of the SARS-CoV-2 virus in saliva or mucus (FDA, ABC)
- Serological tests determine if antibodies formed in the blood in response to the SARS-CoV-2 virus (FDA). They can be used for population surveillance of virus spread but not for active cases (CDC). Earlier this month, the FDA tightened rules on over 100 antibody tests on the market over concerns of inconsistent results (Politico, 5/4) and approved a highly specific and sensitive antibody test (FierceBiotech, 5/4)
- Antigen tests detect the presence of SARS-CoV-2 and can be fast and low-cost but could have higher false-negative rates. More antigen tests are expected to be approved. Antigen tests identify fragments of proteins found on or within the virus from nasal swabs (FDA)
Week of May 4, 2020
- Contact-tracing is one part of safely reopening the economy (Axios 4/30), and big tech companies are both collaborating and competing to launch new tools (Bloomberg 4/29)
- Patients have more access to care now that Health Savings Accounts are permitted for telehealth appointments and OTC medications (New York Times 5/1)
- The first in-home diagnostic test for Covid-19 was approved by the FDA, after weeks of unauthorized tests flooding the market (New York Times 4/21)
- Large diagnostic companies are growing production capacity for Covid-19 tests, but are struggling to fully reopen themselves (Yahoo Finance 4/23)
- The FDA tightened regulations on antibody test accuracy since companies validating their own tests led to inconsistent results (Politico 5/4)
- Hospitals are developing best practices to provide care while observing social distancing protocols, including universal masking and increased use of drive-through clinics (Becker’s Hospital Review 4/27)
- Clear communication, the delegation of authority, and focusing on people and sustainability have helped Seattle’s Swedish Health System respond to Covid-19 (Harvard Business Review 4/21)
- Health systems struggled financially with the halt of elective surgeries, but are laying the groundwork to restart these procedures (Wall Street Journal 4/22)
- Hospital vending machines are growing in popularity as cafeterias close, and healthier options are attracting attention (Eater 4/22)
- Covid-19 has elevated the importance of social determinants of health, and health plans are paying more attention to keep their members safe and healthy at home (MedCity News 5/3)
- Medicaid programs are offering telehealth for the first time, expanding access to care safely. The government of Massachusetts is covering Covid-19 telehealth visits for uninsured patients to combat the spread of the virus (MobiHealthNews 4/24)
- After a Phase III trial, the FDA issued an emergency use authorization for Gilead’s Remdesivir for hospitalized adults and children with confirmed cases of Covid-19 (FDA, 5/1). Hydroxychloroquine was the first drug granted an emergency use authorization, but outcomes have been mixed (The Hill 4/21)
- Hundreds of thousands of clinical trials are on pause as healthcare goes remote and research personnel are redeployed to the front lines (Wall Street Journal 5/4)
- NASA’s Jet Propulsion Lab designed a ventilator specifically for Covid-19 patients in an effort to increase capacity (NASA 4/23)
- As the world has gone remote, telemedicine companies raised $788M in Q1 2020, more than triple the figure in Q1 2019 (FierceHealthcare 4/14)
- The Gates Foundation is shifting gears to focus on Covid-19 and has spent $250M to date (Financial Times 4/26)
- As CMS manages the rollout of $100B in hospital funding, the agency is also monitoring the success of rolling back regulations on services like telehealth (Healthcare Dive 4/17)
- HHS declared that health systems must agree to not send Covid-19 patients surprise bills for treatment if they received CARES Act funding (Kaiser Health News 4/17)
Government & Regulatory
- Patients get more control over their data, and payers share it differently per new rules from HHS (HHS 3/9)
- With mental health deteriorating during isolation, digital behavioral therapy and other digital health solutions are more accessible as the FDA relaxed regulations (FDA 4/14); now, new digital treatments for mental illnesses are coming to market faster (MobiHealthNews 4/22)
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