Immediate Changes Needed for Physicians to Stay in Business During the Pandemic

Practices cannot survive the COVID-19 cash flow crisis

By JEFF LIVINGSTON, MD

Will doctors be able to keep their practices open during the worst pandemic in our lifetime? Our country needs every available doctor in the country to fight the challenges of Covid-19. Doctors working in independent practices face an immediate cash flow crisis threatening their ability to continue services.

The CARES Act was signed into law on Friday, March 27, 2020. The law offers much-needed help to the acute needs of hospitals and the medical supply chain. This aid will facilitate the production of critical supplies such as ventilators and PPE. The law failed to consider the needs of the doctors who will run the ventilators and wear the masks.

Cash flow crisis

Private-practice physician groups experienced an unprecedented reduction in in-office visits as they moved to provide a safe and secure environment for patients and staff. In compliance with CDC guidelines, practices suspended preventative care, nonurgent visits, nonemergent surgery, and office procedures.

These necessary practice changes help keep patients safe and slow the spread of Covid-19. The unintended consequence is an unreported and unrecognized cash flow crisis threatening the viability of physician practices.

The number of self-employed physicians in the US is decreasing. The AMA’s annual Physician Practice Benchmark Survey showed that 47% of all physicians in 2018 were employed. This statistic is misleading as only a fraction of the employed physicians are employed by large hospital systems and health conglomerates who will have the cash flow and resources to manage through the crisis. Physician-owned practices employ the rest.

Many feel physicians are wealthy and do not need assistance. Some doctors are financially well-off and others are not. The personal net worth of a business owner is not relevant in the balance sheet of a business. A catastrophic drop in cash flow is the issue requiring corrective action.

We ask physicians to fight on the front lines, risking their lives without PPE and equipment. Doctors and nurses are getting sick. Some will die. We know it, and we are proud to put our life on the line in service to our nation.

As a society, we must stop and take a moment to think about what we are doing. The majority of US physicians are committed to serving and risking their lives. We are also asking them to lose their livelihoods.

New revenue opportunities

CMS removed restrictions to allow expansion of virtual care through Waiver 1135. Many practices have rapidly expanded their services to implement Telehealth. The harsh reality is that many practices in our country do not have the IT capacity to implement a complicated solution in an expedited manner. Even for those who are able, the revenue generated by virtual care will not offset the lost revenue from the reduction of services.

Telehealth alone is not enough to save healthcare workers jobs. It is a tiny drop in an empty bucket.

Who is at risk?

Practice managers scramble to evaluate options offered through the SBA disaster programs. Provisions in the CARES act prohibit the inclusion of those making above $100,000 in the forgiveness programs for SBA loans. Most practices employ physicians through long term contracts.

Contractual obligations extend beyond doctors. Providers affected include all non-physician providers who extend service and are critical to the health team. This includes Nurse Practitioners, Physician Assistants, Certified Nurse Anesthetists, and Certified Nurse-Midwives.

There is a domino effect that follows physician job loss. Staff in supporting roles for these providers will lose their jobs. A good rule of thumb is three staff members are employed for each physician or non-physician provider. The reduction of one non-physician provider causes three more people to lose their job. Staff falls below the forgiveness threshold, but if the provider is unemployed then staff reductions will follow.

Every contracted health care provider in America who falls above the forgiveness threshold is at risk of losing their jobs. This transcends physician specialty.

Let this sink in. In the middle of the Covid-19 crisis, every doctor and healthcare worker in every specialty in America is imminently at risk of unemployment.

Why is this happening so fast?

Private medical practices function similarly to others in the services industry. Revenue is generated through services rendered. Like any business, revenue is used to make payroll, purchase medical equipment and supplies, software dues, rent, and utilities. Medical practices also must pay for janitorial services, electronic medical records licenses, practice management systems, and equipment leases. While health insurance, phone systems, and retirement plans were covered in the CARES act, the above list was not.

Unlike traditional service industry companies, medical practices are not compensated for services rendered at the time of the transaction. Instead, charges are filed through a third-party payer (Medicare, Medicaid, or an insurance company). When we go to a drive-thru restaurant, we order and pay for our food on the spot. Healthcare services do not function this way.

Red tape associated with our country’s revenue cycle management system creates a lag in payment. Payments are not received for up to 3 months. In my field of obstetrics, no fees are collected until weeks after delivery as pregnancy is paid globally. This lag in payment exacerbates the cash flow crunch for medical practices.

Action is needed now

Medical providers need coordinated action now. We can not wait for private industry solutions. It is not practical for every practice in the country to negotiate terms with each landlord and vendor individually. It is not possible to evaluate all agreements with each pharmaceutical, device, medical supply, and every insurance company. This is not a scalable solution.

Here is the reality. Without immediate governmental action, practices around the country will fail. The US will be faced with an unprecedented crisis of unemployed physicians right at the potential peak of the Covid-19 pandemic.

Today CMS took positive steps with the Accelerated Advanced payment system. This corrective measure only applies to Medicare payments and does not apply to Medicaid or third-party insurance.

Here are actionable items that will help allow doctors to stay in business and help the US health system navigate through the pandemic.

1. Expedited health care provider credentialing process. Allow immediate authorization of any licensed provider, in good standing with their state’s medical board, to provide all services for Medicare, Medicaid, and any third-party insurance plans. The credentialing process can take between 90–120 days. As doctors get sick and die, there is no time for bureaucratic red tape. CMS expedite credentialing nationally for Medicare and third-party payers. Governors can mandate expedited credentialing for state-run Medicaid plans. This simple step will allow providers to contribute immediately and keep patients alive as physicians get sick and die.

2. Moratorium on medical office evictions. Commercial protection against eviction is needed for medical practice office leases during the pandemic. Texas Governor Greg Abbott passed protection for residential leases. Medical practices need similar protection. A mandate could be identical to the executive action announced by California Governor Gavin Newsome.

3. Suspend out-of-network penalties. It is not safe to enforce network restrictions during the pandemic. Allow physicians and patients to seek care in hospitals and medical sites of service not experiencing capacity limitations. We need the freedom to direct care where it is safe and where there is room. This will reduce the burden on hospital capacity.

This logical and necessary action will save lives. CMS can enact this simple step for Medicare and third-party payers. Governors can mandate this step for state-run Medicaid plans. Failure to do so will cost lives.

4. Suspend the reduction in reimbursement for nonphysician providers. Nonphysician providers are a critical part of the health team. Nonphysician providers include Nurse Practitioners, Physician Assistants, Certified Nurse Anesthetist, and Certified Nurse-Midwives. Currently, they are reimbursed at a lower rate than physicians for the same services.

As physicians begin to contract Covid-19, all available providers will be needed. Care provided by nonphysician providers should be reimbursed at the standard physician rate.

5. Waive Clia restrictions to allow and encourage point of care testing Physician practice sites will be essential to scaling up widespread Covid-19 testing. New FDA approved point of care Covid-19 tests are coming to market. Waiving restrictions will allow for an orderly rollout. Containment of the virus is dependent on our ability to test. We can not lose lives while we wait for Clia certifications.

6. Extend Postpartum Medicaid benefits to one year Medicaid coverages vary by state. Currently, in Texas women transition off Medicaid sixty days postpartum. Extending benefits will provide healthcare access to low-income women and reduce hospital burden by avoiding ER visits.

Tubal ligations are not being scheduled due to the mandated postponement of elective surgery. Low-income women will not have family planning coverage when the pandemic is over. Each state must determine eligibility for Medicaid for postpartum women. The result of this action will be fewer unwanted pregnancies, give women control over their bodies, and reduce abortions.

7. Remove restrictions on Ambulatory Surgery Centers The idea of reducing elective surgery was sound. Unfortunately, broad statements by the CDC lead to a variety of conflicting resolutions by various medical specialty governing boards. ASC utilization decisions should be made locally by their medical board and medical directors. Ambulatory surgery centers play a key role in reducing hospital burden and preventing local hospitals from reaching surge capacity. Medical directors need the freedom to work with local hospitals to guide patients to the safest possible treatment options.

8. Exempt Healthcare providers from the $100K threshold for debt forgiveness One of the purposes of the CARES act is to maintain a functional healthcare system to save lives during this pandemic. Allowing healthcare providers to be included in the SBA disaster relief debt forgiveness program would help us achieve the goal.

9. Mandate extended payment plans Physicians were hoping to see legal requirements in the CARES act requiring vendors to extend payment options to medical practices. Unfortunately, this did not occur. Practices need extended terms for all items in the medical supply chain including vaccines, devices, equipment leases and pharmaceutics to allow us to function during the pandemic.

There is no easy solution to this problem. I suggest Congress enact the mandated matching receipts of physician practices with payments to vendors for supplies and equipment. For example, physicians are reimbursed by insurance carriers on a delayed revenue cycle. Reimbursement is typically delayed up to 3 months. Congress could mandate vendors are not paid until the practice is reimbursed by Medicare, Medicaid or third-party payers.

Time is crucial

Medical practices across the country need a lifeline to stay in business. The United States passed 139,000 Covid-19 cases today. When this article is published, that number will be higher. The death toll will rise. I can’t believe I have to say it, but doctors and non-physician providers are needed to help manage the Covid-19 pandemic.

We will put on our lives on the line for our patients.

Isn’t our Government willing to save ours?

Jeff Livingston, MD is an OBGYN practicing in Texas.

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The Costs of Covid-19: What Health Plans & Employers Are Saying About Covering Care | WTF Health

By JESSICA DaMASSA, WTF HEALTH

“[Employers’] top priority is getting their employees and their family members the appropriate care, but there are a lot of unknowns about how this is going to impact their actual total cost of care…”

As Covid-19 testing and treatment rise in U.S., many people — and their employers — may be starting to wonder: who is going to pay for this? How much is this going to cost?

Castlight Health’s CEO, Maeve O’Meara, talks to us about all-things healthcare cost, coverage and benefits administration, drawing from her position leading a company that focuses on helping people make sense of the health insurance benefits they receive through their employers or directly from health plans. 

What has employers and health plans most concerned? Making sure people are aware of changes to their plans so they know what’s covered (and what’s not), and when and where to go for care are the top of the list, according to Maeve.

Castlight’s recent publication of a ‘Covid19 Cost Analysis Report’ (link below) supports that point, outlining the variances in costs for Covid-19 testing and related fees. The key takeaway to note: While fees may be waived for the Covid-19 test itself, supporting services like doctor’s visits, chest x-rays, bacterial or blood culture tests, etc. are probably not and those costs can vary significantly depending on the point-of-care.

Ultimately, these costs are going to add up, and employers and health plans are already beginning to talk about what this will mean post-outbreak. “They’ve estimated how much it will cost to cover the covid test, how much will it cost to cover the actual treatment, and what are the implications in terms of how they think about 2021 and being able to contribute to employee plans,” says Maeve. 

“The offsetting factor here is that there is this massive delay of elective procedures — hips, knees, heart, there’s a lot in that bucket — and so how that cost and [those] services are offset is not at all clear right now.” 

In addition to the Cost Analysis Report, Castlight has also created an open-source Covid19 Testing Site Directory identifying 1,500 different testing sites nationwide and hoping to crowdsource more. 

Covid19 Cost Analysis Report: 

The Real Costs of Seeking Care for COVID-19 Vary Across and Within Major U.S. Cities

Covid19 Testing Directory:

https://my.castlighthealth.com/corona-virus-testing-sites/

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Pandemics Are the Mother of Invention

By KIM BELLARD

If, as they say, necessity is the mother of invention, then you’d have to say that the COVID-19 pandemic is proving to be the mother of invention and innovation.  And, like Isaac Hayes sang about Shaft, it is a “bad mother…(shut your mouth).”

Many believe that the Allies won WWII in large part because of how industry in the U.S. geared up to produce fantastic amounts of weapons and other war materials.  It took some time for businesses to retool and get production lines flowing, during which the Axis powers made frightening advances, but once they did it was only a matter of time until the Allies would prevail.

Similarly, COVID-19 is
making scary inroads around the world, while businesses are still gearing up to
produce the number of ventilators, personal protective equipment (PPE), tests,
and other badly needed supplies.  COVID-19 is currently outnumbering
these efforts, but eventually we’ll get the necessary equipment in the needed
amounts.  

Eventually.  

What intrigues me, though,
is how people are innovating, inventing new solutions to the shortages we
face.  I want to highlight a few of these:

Hospitals: China received a lot of press when they built COVID-19 hospitals in a matter of days, and now that is starting to happen here. In New York City, the U.S. current epicenter, the Army Corps of Engineers has, within a matter of days, repurposed the Javits Convention Center into an overflow hospital with almost 3,000 beds, making it the largest hospital in the city.  It will serve primarily non-COVID-19 patients, allowing other hospitals to focus on COVID-19 patients.

Javits Center Hospital

Governor Cuomo has set a goal of 1,000 bed overflow hospitals in each of the five boroughs, the other sites being Brooklyn Cruise Terminal, the Aqueduct Racetrack facility in Queens, CUNY Staten Island and the New York Expo Center in the Bronx.  

In addition, another field hospital is literally being set up in the field, in this case Central Park’s East Meadow, across from Mt. Sinai Hospital.  It will have ICU capabilities.

Testing: When this is all over, there will be many
analyses about how the U.S. botched coronavirus testing.  As of this
writing, although testing has become vastly more available, it still is well
below what is needed, and we do not have a good understanding of how widespread
the virus has spread and who is currently spreading it.

Abbott Labs COVID-19 Test. Source: Abbott Labs

Part of the problem is
that, even for those who can get tested, the results can take hours or even
several days to get results.  During that time, they may be asymptomatic
and further spread the virus.  All that may be changing.  

Abbott Labs has gotten approval for a point-of-care test that can give
results in as few as five minutes.  FDA Commissioner Steve Hahn and former
FDA Commissioner Scott Gottlieb both called it a “game
changer.” 

Another game changer is the ability for individuals to self-administer diagnostic tests, alleviating the need to go to testing facilities, and risk exposure for health care workers.  A new study has found that such testing can be as accurate as physician-administered tests.  Such tests are awaiting FDA approval.

PPE: There similarly are not enough masks and other personal protective equipment.  Health care workers are being told to change them after each contact with infected patients, and, as a result, the numbers being used are skyrocketing.  President Trump might suspect that something nefarious is going on, but the need is real.  

Manufacturing of PPE is ramping up, but it will take time to catch up to need.  So Battelle Labs has developed a decontamination system that can allow masks to be reused up to twenty times.  It took intervention from Ohio Governor DeWine to persuade President Trump and FDA Commission Hahn to grant FDA approval in a matter of days, but now the system is quickly being ramped up to full capacity.  

Ventilators: Ventilators are one of the most troublesome
bottlenecks in treating COVID-19 patients.  When such patients go into
respiratory distress, as an alarming number do, it is quite severe and lasts
for much longer than for other ICU patients.  As a result, the ventilator
supply has been badly stretched.  Hospitals are having to make tough
choices about who gets one and who doesn’t. Governors are fighting over where
additional ventilators get sent, and manufacturers are scrambling to increase
production.

Some hospitals have innovated by using single respirators to serve several patients simultaneously, although the safety of this is unclear.  Others are using continuous positive airway pressure machines (CPAPs), more typically used to treat conditions like sleep apnea, although, again, the safety of this is in question.

Fortunately, the engineers are at it.  In Italy, some clever people started 3D printing badly needed respirator values, for free, when hospitals couldn’t get them from the original manufacturers.  

Dyson CoVent Ventilator

Never one to be outdone, James Dyson, of vacuum cleaner fame, developed an entirely new ventilator in an astonishing ten days, and is already producing them.  Virgin Orbit, which normally, you know, sends things into space, has developed its “mass producible bridge ventilators” and is hoping to begin production in early April, pending FDA approval.  

Not to be outdone, within two weeks an MIT team developed an “open source, low cost” ventilator design which it believes can be built for as little as $100 (a normal ventilator costs as much as $30,000).  They are waiting for, you guessed it, FDA approval, and warn that these “have to be manufactured according to FDA requirements, and should only be utilized under the supervision of a clinician.”  In other words, don’t try this at home.

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These are just a few examples.  I didn’t discuss, for example, how new treatments and vaccines are being rushed through at a breakneck pace, or the countless innovations front line health care professionals are being forced to come up with every day as they face the crush of very sick, infectious COVID-19 patients.  

We are, indeed, at war with the coronavirus, and there are going to be casualties.  A lot of them.  The number of deaths will shock us.  But as shocked as we may become, as overwhelmed as we may feel, we’re also going to be amazed at the creativity and innovation people are bringing to the fight.  In the end, though, that and the heroics of our health care workers are what is going to win the war.

Kim Bellard is editor of Tincture and thoughtfully challenges the status quo, with a constant focus on what would be best for people’s health.

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This treatment could save your life – COVID-19 and Convalescent Plasma Therapy

Ajay Kohli

Vinay Kohli

Chitra Chhabra Kohli

By CHITRA CHHABRA KOHLI MD, AJAY KOHLI MD, and VINAY KOHLI MD, MBA

With a doubling time of cases estimated between 3 days within the U.S. and about 6 days globally (at the time of this writing) COVID-19 is demonstrating its terrifying virulence as it spreads across the world.

What’s perhaps equally terrifying, if not more, is the absence of a known cure or treatment plan for COVID-19. While there has been a lot of attention focused on Hydroxychloroquine and Azithromycin, there has been debate on the scientific validity of these treatment options, either as therapy or as prophylaxis. The impact of a solution certainly has far reaching potential, the scope of the challenge is overwhelmingly large. The editor-in-chief of Science recently wrote that the efforts to find a cure are not just ”fixing a plane while it’s flying — it’s fixing a plane that’s flying while its blueprints are still being drawn.”

There is a promising therapy that may help us weather the COVID-19 storm and, perhaps, flatten the curve. It’s based around science that defines immunology and has already been used in many different diseases, going as far back as the 1918 flu pandemic. This potential treatment is convalescent plasma therapy — using antibodies from patients who have recovered from COVID-19 and then transfusing them into patients who are currently mounting an immune response against the rapidly rising viral loads of COVID-19.

How COVID-19 Attacks

To understand how convalescent plasma therapy,
or really how any therapy can play a
role in treatment, we need to understand how the disease, COVID-19, attacks.

COVID-19 is transmitted through direct and indirect human-to-human contact, with community spread increasing everyday. The R₀ (pronounced R nought) of COVID-19 is estimated around 2.2 (movie star Kate Winslet simplifies this complex epidemiological concept in less than a minute and a half, in this brilliant scene from the movie Contagion, included here). Among the many sinister qualities of the virus is its patience — it has an incubation period which can last up to 14 days — making it particularly virulent because of its ability to be spread unsuspectingly. Clinically, it presents often with fever, dry cough, shortness of breath and other respiratory symptoms, although it’s reported in a not insignificant minority to also present with gastrointestinal complaints.

After the initial symptomatic presentation it
begins to unleash its full force, manifested through a cytokine storm.

The body’s immune system is a complex army used to defend against the attacks of invaders, like COVID-19.  Cytokines — small proteins that unleash a pro-inflammatory fight against invaders — are typically balanced by a legion of lymphocytes, cells responsible for clearing out inflammation.  When COVID-19 invades its host it unleashes an unfair war — causing a toxic cytokine storm with lymphopenia (a reduction in the number of lymphocytes) — leaving the body susceptible to an unchecked inflammatory state. This can go on to cause lung injury, leading to acute respiratory distress syndrome, shock, organ failure and potentially death.

This is what was seen within the original cohort of patients from Wuhan who all had increased IL-6 (an inflammatory cytokine) and other markers of inflammation (increased neutrophils and C-Reactive Proteins) with decreased lymphocytes. Furthermore, these patients with increased neutrophils and decreased lymphocytes were sadly shown to have a higher rate of disease severity and death.

It’s a
battle between the multiplying COVID-19 viral load and the body’s immune
system. However, even before the battle begins, COVID-19 causes a decrease in
the lymphocyte count, essentially destroying the armor of the immune system.
With an unchecked increase in viral count, and a hobbled immune system, the
lungs, are the early casualty in the war.

Source: APJAI

Role of Plasma

As the virus count increases within the body,
there are progressively higher rates of inflammation with decreased lymphocytes
to clear this inflammation. Could patients be administered therapy in this
critical time to help bolster their immune system against this virus?

In limiting the increase in viral load count, convalescent plasma therapy could do precisely this. While this has already been used with H5N1 avian influenza and H1N1 influenza, and there has been at least one study in patients with COVID at the Shenzen Third People’s Hospital in China. Their efforts showed that critically ill patients with COVID-19 improved on multiple different parameters after the administration of plasma therapy.

Their study selected patients who were previously
diagnosed with COVID-19 in the past, but had negative viral loads of SARS-CoV-2
(the causative agent for COVID-19) at the time of blood donation. Additionally,
the donors were required to be asymptomatic for at least 10 days with serum
SARS-CoV-2–specific ELISA antibody titer greater than 1:1000 as well as a
neutralizing antibody titer greater than 40 (similar parameters to the
administration of plasma therapy in prior pandemics, such as H1N1). After blood
donation, 400 mL of convalescent plasma was obtained from each donor by
apheresis, with the plasma immediately transfused to critically sick recipients
on the day it was obtained.

The plasma recipients showed a very promising response — including decreased viral loads, improved PaO₂/FiO₂ as well as decreased body temperature and time to discharge (see figure below). Promisingly, these responses were similar to the patients who had been administered convalescent plasma therapy in other diseases.

Source: Shen, Wang and Zhao, JAMA 2020

So why did these critically ill patients who
were all receiving potent antivirals without improvement suddenly get
better?  The answer lies in the ability
to control the viral load. Prior to the administration of convalescent plasma
therapy, the patients were all being treated with potent antivirals but their
viral loads were still detectable and rising. After the administration of
plasma therapy, their viral loads declined to undetectable levels. In the
setting of a reduced viral load, the patients were able to compound
acceleration of infected cell clearance.

What is plasma? Plasma makes up 55% of the body’s total blood volume and contains a variety of important proteins — most notably antibodies. In simplified terms, antibodies essentially are ‘memory’ proteins that become primed to detect ‘invaders’ after a host becomes exposed — either through infection or vaccine. Antibodies allow hosts to not only better detect ‘invaders’ and clear them out of body, but also improve the efficiency and efficacy of the immune system to clear ‘invaders’ out quickly, thereby minimizing disease progression and severity. It is this principle — ‘priming the immune system’ — that underlies the use of vaccines.

The study performed at the Shenzen Third
People’s Hospital in China was limited because it was only performed in 5
patients. However, convalescent plasma therapy has shown promise through
numerous prior pandemics. The risks and benefits of convalescent plasma therapy
are well known, although work still has to be done to evaluate it further,
particularly within the setting of COVID-19.

Implementation

It must be stated that is not the cure for all.

The FDA has already released plasma therapy as an emergency Investigational New Drug Application (eIND) for use in patients with serious or immediately life threatening emergencies. The FDA did add, however, that clinical trials still have to be performed to determine the safety and efficacy of plasma therapy before administering plasma therapy routinely. In the absence of options, this could be used for critically ill patients that are unable to mount a response to the disease.

Mount Sinai in New York City has already started administering antibody rich plasma therapy for the most critically ill patients. Additional healthcare institutions are already looking at starting clinical trials while nearly every major US academic center is looking to expand their treatment options with convalescent plasma therapy.

Perhaps the most comprehensive resource is the National COVID-19 Convalescent Plasma Project – https://ccpp19.org/. Based out of Mayo Clinic, this website serves as a resource for healthcare providers who are looking to use plasma therapy for either clinical trials or treatment. This also serves as a platform for patients who have recovered from COVID-19 to donate their plasma or for patients/family members considering the treatment.

Diagnostics

The power of the immune system is currently
being harnessed as the race for a vaccine begins. However, while we wait for a
vaccine, mapping the antibody response can be critical in the development of
new tests.

Abbott Laboratories recently launched a molecular point of care swab test that has received Emergency Use Authorization (EUA) by the FDA to detect viral loads within a short period of time. This test utilizes RT-PCR (Reverse Transcriptase – Polymerase Chain Reaction) to determine if a sample is positive within 5 minutes and negative within 13 minutes.

There is an additional rapid COVID-19 IgG/IgM antibody blood test. This test had already been deployed in China, where it had high sensitivity (88.66%) and specificity (90.63%). This could be most useful in preventing asymptomatic spread where patients can test false negative by swab PCR, particularly in the early stages of infection. COVID-19 spread is estimated to start within the lungs and may not show up in the early phase with a swab test, leading to a false negative result.

This could be particularly useful in filling the void of testing asymptomatic carriers of COVID-19, with a false negative RT-PCR, and then placing them in quarantine. This is not unique to COVID-19, as patients with Zika demonstrated to be asymptomatic carriers as well.  While the window to implement this may be missed within New York City, there could be a potential role in areas where COVID-19 has yet to spread and surge.

Future steps

As the number of patients with COVID-19 increases, resources – from ventilators for the patients to personal protective equipment for the providers – are already being strained. This is another area where convalescent plasma therapy could play a role. With variations in underlying baseline immunocompetence, it is inevitable that patients will either recover or worsen. Those that recover could potentially hold a life-saving treatment that could save the most critically affected or perhaps even prevent the deteriorating patient from becoming critically ill.

In the absence of a cure, and in the long wait for a vaccine, convalescent plasma therapy is a solution that could give a suffocating world a much needed breath of fresh air.

Dr. Chitra Chhabra Kohli is Medical Director and Consultant Surgical Pathologist at Coffeyville Regional Medical Centre, Coffeyville, Kansas.

Dr. Vinay Kohli is an independent pathologist and former Professor from the Department of Pathology, King George’s Medical University, India.

Dr. Ajay Kohli is a radiology resident physician at the Hospital of the University of Pennsylvania in Philadelphia, PA.

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False Negative: Testing’s Catch-22

By SAURABH JHA, MD

In a physician WhatsApp group, a doctor posted he had fever of 101° F and muscle ache, gently confessing that it felt like his typical “man flu” which heals with rest and scotch. Nevertheless, he worried that he had coronavirus. When the reverse transcription polymerase chain reaction (RT-PCR) for the virus on his nasal swab came back negative, he jubilantly announced his relief. 

Like Twitter, in WhatsApp emotions quickly outstrip facts. After he received a flurry of cheerful emojis, I ruined the party, advising that despite the negative test he assume he’s infected and quarantine for two weeks, with a bottle of scotch. 

It’s conventional wisdom that the secret sauce to fighting the pandemic is testing for the virus. To gauge the breadth of the response against the pandemic we must know who and how many are infected. The depth of the response will be different if 25% of the population is infected than 1%. Testing is the third way, rejecting the false choice between death and economic depression. Without testing, strategy is faith-based. 

Our reliance on testing has clinical precedence – scarcely any decision in medicine is made without laboratory tests or imaging. Testing is as ingrained in medicine as the GPS is in driving. We use it even when we know our way home. But tests impose a question – what’ll you do differently if the test is negative? 

That depends on the test’s performance and the consequences of being wrong. Though coronavirus damages the lungs with reckless abandon, it’s oddly a shy virus. In many patients, it takes three to four swabs to get a positive RT-PCR. The Chinese ophthalmologist, Li Wenliang, who originally sounded the alarm about coronavirus, had several negative tests. He died from the infection.

In one Chinese study, the sensitivity of RT-PCR – that’s the proportion of the infected who test positive – was around 70%. To put this in perspective, 1000 people infected with coronavirus: 700 will test positive but 300 will test negative. 

Is this good enough?

300 “false negative” people may believe they’re not contagious because they got a clean chit and could infect others. False negatives could undo the hard work of containment. 

Surely, better an imperfect test than no test. Isn’t flying with partially accurate weather information safer than no information? Here, aviation analogies aren’t helpful. Better to think of a forest fire. 

Imagine only 80% of a burning forest is doused because it’s mistakenly believed that 20% of the forest isn’t burning because we can’t see it burning. It must be extinguished before it relights the whole forest, but to douse it you must know it’s burning – a catch-22. That “20% of the forest” is a false negative – it’s burning but you think it’s not burning. 

Because coronavirus isn’t planning to leave in a hurry and long-term lockdown has grave economic consequences, testing may enable precision quarantining of people, communities, and cities. Rather than applying a one-size-fits-all lockdown on the whole nation, testing could tell us who can work and who should stay home. Why should Austin, if it has a low prevalence of infection, shut shop just because of New York City’s high prevalence? 

Testing enables us to think globally but act locally. But it’s the asymptomatic people who drive the epidemic. To emphasize – asymptomatics are yet to have symptoms such as cough and fever. They’re feeling well and don’t know they’ve been colonized by the virus. Theoretically, if we test en masse we can find asymptomatics. If only those who test positive are quarantined, the rest can have some breathing space. Will this approach work?

RT-PCR’s sensitivity, which is low in early illness, is even lower in asymptomatics, likely because of lower viral load, which means even more false negatives. The virus’s average incubation time of five days is enough time for false negative asymptomatics — remember they resemble the uninfected — to visit Disney World and infect another four. 

Whether false negatives behave like tinder or a controllable fire will determine the testing strategy’s success. The net contagiousness of false negatives depends how many there are, which depends on how many are infected. To know how many are infected we need to test. Or, to know whether to believe a negative test in any person we must test widely – another catch-22. 

Maybe we need a bigger test.

Chest CT is an alternative. It’s rapid – takes less than an hour whereas RT-PCR can take over a day to report. In one study CT had a sensitivity of 97 % in symptomatic patients and was often positive before RT-PCR. But there are caveats. 

The real sensitivity of CT is likely much lower than 97% because the study has biases which inflate performance. CT, like RT-PCR, has a low sensitivity in early illness and even lower sensitivity in asymptomatic carriers for the same reason – lower viral load. Furthermore, CT has to be disinfected to prevent spread, which limits its access for other patients.

Coronavirus’s signature on CT – white patches in lungs, known as ground glass opacities – doesn’t have the uniqueness of the Mark of Zorro, and looks like lung injury from other rogue actors, which means we can mistake other serious conditions for coronavirus. Imagine hyenas in wolf’s clothing. 

No test is perfect. We still use imaging despite its imperfections. But, let’s ask: what’d you do differently if the test is negative and you have mild symptoms of cough and fever? Should you not self-isolate? What if you’re falsely negative and still contagious? If the advice dispensed whether the test is positive or negative is the same – i.e. quarantine for 2 weeks – what’s the test’s value? 

Perhaps people will more likely comply with voluntary quarantine if they know they’re infected. Information can nudge behavior. But the logical corollary is that to comply with social distancing you need to be tested. People flocking to CT scans to affirm they’re not infected could infect those hitherto uninfected. A pandemic is no time to test nudge theories.

Does that mean testing has no value? Testing is valuable in managing populations. To individuals, the results must be framed wisely, such as by advising those who test positive to quarantine because “you’re infected” and those who test negative to keep social distancing because “you could still be infected.” 

Even when policy goals are uniform, messaging can be oppositional. “Get yourself tested now” contradicts “you must hunker down now.” When messages contradict, one must choose which message to amplify. 

The calculus of testing can change with new tests such as antibodies. The value of testing depends also on what isolation entails. A couple of weeks watching Netflix on your couch isn’t a big ask. If quarantine means being detained in an isolation center fenced by barbed wires, the cost of frivolous quarantining is higher and testing becomes more valuable. 

I knew the doctor with the negative RT-PCR well. He’s heroically nonchalant about his wellbeing, an endearing quality that’s a liability in a contagion. In no time he’d be back in the hospital; or helping his elderly parents with grocery. Not all false negatives are equal. False negative doctors could infect not just their patients but their colleagues, leaving fewer firefighters to fight fires. 

It is better to mistake the man flu for coronavirus than coronavirus for the man flu. All he has to do is hunker down, which is what we should all be doing as much as we can. 

Saurabh Jha is a contributing editor to THCB. He can be reached @RogueRad.

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Covid-19 & Digital Health in Italy: “10 Years of Evolution in 10 Days” | WTF Health

By JESSICA DaMASSA, WTF HEALTH

“It’s fair to say that, in Italy, we are doing 10 years of digital health evolution in 10 days.”

Our “man-on-the-street” in Italy (well, man-sheltered-in-place in Italy) Roberto Ascione, CEO of Healthware, reports in on the Covid-19 outbreak and what’s happening with digital health startups, health system partners, and hospitals as Italians continue battling at the forefront of the coronavirus outbreak.

A few weeks ahead of the U.S., there are many things to learn about Covid-19 testing, treatment, outcomes, and timing from the experience in Italy, including some foresight on how pathways for telehealth and digital health continue to evolve as conditions become more serious and the outbreak progresses. (For all you Gretzky fans, this is “skating to where the puck will be” kind of stuff…)

Some navigational guidance on this chat which took place March 26, 2020:

• Update on Italian Covid-19 outbreak from health industry insider
• 10:25 minute mark: Digital Health startup case study, Paginemediche, self-triage chatbot data from 70K Italians, data sharing with Italian government & WHO, telehealth model flipping to give overwhelmed physicians opportunity to triage and “invite” patients based on needs
• 19:10 mark: How to work with Italian digital health startups to advance Covid-19 work

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Health in 2 Point 00, Episode 114 | COVID-19 Stimulus Package & Startup Responses

Today on Health in 2 Point 00, we have a viewer question! For our friends who are wondering what will happen to all the IPOs that were supposed to happen this year, I weigh in on how this crisis will impact IPOs and startup funding. On Episode 114, Jess asks me about the stimulus package granting $117 billion to hospitals and for my thoughts on all the startups coming up with ways to address COVID-19. A few startups that come to mind include Conversa with its virtual care conversation, Coronavirus Health Chats, Biofourmis which is looking for ways to track infected people earlier through its AI-powered arm sensor, and Surveyor Health leveraging its data analytics platform as well. For more on this, check out covid19healthtech.com where my colleagues at Catalyst have put together a resource hub for health tech solutions. —Matthew Holt

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The New Scarlet Letter

By KIM BELLARD

This piece is part of the series “The Health Data Goldilocks Dilemma: Sharing? Privacy? Both?” which explores whether it’s possible to advance interoperability while maintaining privacy. Check out other pieces in the series here.

If you live in one of the jurisdictions that have imposed stay-at-home requirements, you’re probably making your essential excursions — grocery store, pharmacy, even walks — with a wary eye towards anyone you come across.  Do they have COVID-19?  Have they been in contact with anyone who has?  Are they keeping at least the recommended six feet away from you?  In short, who is putting you at risk?   

Well, of course, this
being the 21st century, we’re turning to our smartphones to help us try to
answer these questions.  What this may lead to remains to be seen.

We long ago seemed to
shrug off the fact that our smartphones and our apps know where we are and
where we have been.  No one should be surprised that location is of
importance to tracking the spread of COVID-19.  No one should be surprised
that it is already being used.  We may end up being surprised at how it
will be used.

Baidu coronavirus map app (Qilai Shen/Bloomberg News)

Last week Israel granted its
domestic security agency emergency powers to track the mobile phone data of
people who have (or may have) coronavirus.  The intent is for the health
ministry to track whether such persons are adhering to quarantine rules, and
possibly to alert others who had previously come in contact with them. 
  

China is using the
AliPay Health Code to assign color codes to individuals based on their known
health status — green, yellow, red.  No one is admitting exactly what the
codes mean or how they are determined, but The New York Times did an analysis that:

found that the system does more than decide in real time
whether someone poses a contagion risk. It also appears to share information
with the police, setting a template for new forms of automated social control
that could persist long after the epidemic subsides.

The system is used in
real time to determine, for example, who can board mass transit or use public
housing.  It is being rolled out nationwide, despite the lack of
transparency about how the codes are determined, used, or updated.  As one
citizen told The Times: “Alipay
already has all our data. So what are we afraid of? Seriously.”

Seriously.  

Singapore has developed a tool —
TraceTogether — that uses Bluetooth to track whose phones have been in close
contact, and for how long.  If someone then tests positive for COVID-19,
the health ministry can easily determine who has been in contact with
them.  It supposedly does not collect name or even location, but the
health ministry can identify individuals if deemed “necessary.” 
The government is making the technology freely available to developers
worldwide.  

South Korea is using smartphone data to create a publicly available map of
movements of known coronavirus patients, and aggressively message those who
might have come in contact with them.  As The Times also reported:

South Koreans’ cellphones vibrate with emergency alerts
whenever new cases are discovered in their districts. Websites and smartphone
apps detail hour-by-hour, sometimes minute-by-minute, timelines of infected
people’s travel — which buses they took, when and where they got on and off,
even whether they were wearing masks.

Unfortunately, the
information about their movements is having significant ripple effects,
disclosing destinations users might have preferred not be public, or attaching
a stigma to places they frequented. One person told The Guardian: “I thought I only had to protect my health, but now I think there
are other things more scary than the coronavirus.”

In the U.S., volunteers
from several big tech companies built covidnearyou,
which allows people to self-report such facts as any symptoms, travel history,
or exposure to people who have tested positive.  Anyone can then use their
map to determine if there are affected individuals near them.  

MIT’s Media Lab has
developed Private Kit: Safe Paths, “An app that tracks where you have been
and who you have crossed paths with—and then shares this personal data with
other users in a privacy-preserving way.”  Unlike efforts in some
other countries, the data is encrypted and does not go through a central
authority.  MIT Technology Review says:

This lets users see if they may have come in
contact with someone carrying the coronavirus—if that person has shared that
information—without knowing who it might be. A person using the app who tests
positive can also choose to share location data with health officials, who can
then make it public.  

Going one step further,
two San Francisco hospitals have developed a smart ring that is “able to detect body temperature
and pulse.”  It is aimed at health care professionals and workers,
such as ER doctors, as an early indicator of COVID-19 exposure.  It’s
probably only a matter of time before laypersons demand a version.

One can easily imagine
such a smart ring being connected to a smartphone app, perhaps even generating
a color code, and broadcasting the individual’s status and location to others
worried about potential exposure.  I bet Alibaba would be happy to help.

Everything else being
equal, it’s good to know who represents a risk to us.  Typhoid Mary became Typhoid Mary because people around her didn’t know
she was a carrier.  It would be in the public benefit to ensure that
people can get warning about other people who are most likely to be infectious
with COVID-19.

That being said,
everything else is not equal.  We don’t have a good understanding of when
people with COVID-19 are most infectious, how COVID-19 is most likely
transmitted, or how exposure to such people increases risk of third-party
transmission.  Tagging people and then broadcasting that tag, along with
location and even identity, could put people at risk of discrimination (e.g., refused
service or contact) and even attacks.  

As one privacy
expert told The Times: “That
could extend to anyone, to suddenly have the status of your health blasted out
to thousands or potentially millions of people.  It’s a very strange thing
to do because, in the alleged interest of public health, you are actually
endangering people.”

And we need to bear in
mind that whatever technology we bring to bear on this public health problem
could subsequently be used for other problems, public health or other.  We
increasingly live in a surveillance society, and that can be to our benefit —
or to our detriment.  We don’t always realize the slippery slope we’re on
until the slide has become irreversible.  

I’m all for using technology to address public health crises.  I’m just not clear what the ultimate price we’re going to have to pay for that, and that makes me nervous.  

Kim Bellard is editor of Tincture and thoughtfully challenges the status quo, with a constant focus on what would be best for people’s health.

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The THCB Gang Episode 2, Today at 1pm PT/4pm ET

We are back today with our new live show “The THCB Gang” that will be preserved as a weekly podcast and available on our Itunes & Spotify channels. Each week 4-6 semi-regular guests drawn from THCB authors and other assorted old friends of mine will shoot the shit about health care business, politics, practice, and tech. It should be fun but serious and informative!

To kick off this week, joining me I’ll have Michael Millenson (@MLMillenson), Grace Cordovano (@GraceCordovano), Vince Kuraitis (@VinceKuraitis) & Brian Klepper (@bklepper1). Join us at 1pm PT and 4pm ET right here! Hopefully if I don’t screw up too badly we will repeat this every week at the same time with a variety of guests! — Matthew Holt

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Infection Control for COVID-19 Imaging

By STEPHEN BORSTELMANN, MD

Occasionally, you get handed a question you know little about, but it’s clear you need to know more.  Like most of us these days, I was chatting with my colleagues about the novel coronavirus. It goes by several names: SARS-CoV-2, 2019-nCoV or COVID-19 but I’ll just call it COVID.  Declared a pandemic on March 12, 2020 by the World Health Organization (WHO), COVID is diagnosed by laboratory test – PCR.  The early PCR test used in Wuhan was apparently low sensitivity (30-60%), lengthy to run (days), and in short supply.  As CT scanning was relatively available, it became an important diagnostic tool for suspected COVID cases in Wuhan.

The prospect of scanning thousands of contagious patients was daunting, with many radiologists arguing back and forth about its appropriateness.  As the pandemic has evolved, we now have better and faster PCR tests and most radiologists do not believe that CT scanning has a role for diagnosis of COVID, but rather should be reserved for its complications. Part of the reason is the concern of transmission of COVID to other patients or healthcare workers via the radiology department.

But then someone asked: “After you have scanned a patient for COVID, how long will the room be down?” And nobody really could answer – I certainly couldn’t.  A recent white paper put forth by radiology leaders suggested anywhere from 30 minutes to three hours. A general review of infection control information for the radiologist and radiologic technologist can be found in Radiographics.

So, let’s go down the rabbit hole of infection control in the radiology department. While I’m a radiologist, and will speak about radiology-specific concerns, the fundamental rationale behind it is applicable to other ancillary treatment rooms in the hospital or outpatient arena, provided the appropriate specifics about THAT environment is obtained from references held by the CDC.

The basics that you know:

Patients transported to the radiology department should be covered by a clean sheet and wear a mask.  HCPs with direct patient contact with suspected or confirmed COVID patients should use their personal protective equipment (PPE), including a N95 or P99 mask or respirator, eye coverage, gloves, and gown.

What you might not know:

Currently, COVID is thought to be spread by respiratory droplets or direct contact with contaminated surfaces. It is not believed to transmit by a frank airborne route. However, a small infection control study during an outbreak of the MERS coronavirus was concerning for either fomite vectors or a transmission mechanism in between droplet and airborne, with the smallest droplets instantly desiccating in air, resulting in transmission beyond 6 feet. CDC recommendations published in 2003 include a delay in terminal cleaning until air exchange has removed potentially infectious particles. In radiology diagnostic suites, with a minimum recommended 6 total air exchanges per hour (ACH), 99% efficiency in particle removal is 46 minutes and 99.9% removal is 69 minutes. For radiology angiography suites, with a higher recommended minimum ACH/hr of 15, 99% efficiency in particle removal is 18 minutes and 99.9% removal is 28 minutes.  The formulas for calculating the ACH and the time until reaching particulate clearance are given below: 

Figure 1: Time to particulate clearance
 % of particles removed is 99 or 99.9 as given above

Figure 2 – Clearing times vs ACH¹⁸

Of course, there are assumptions in these calculations, and if
your facility is actively treating COVID patients, you may want to meet with
your facilities management team for a more definitive answer.

One major assumption is that there is not sustained virus released – something that might not be true in a ventilated patient. In fact, activities that create aerosols, like mechanical ventilation, CPAP/BiPAP, suctioning or intubation can cause COVID to remain aerosolized for up to three hours.

Surface Cleaning:

After waiting a safe period for air exchange, terminal cleaning should be performed. COVID has been shown to survive up to 72 hours on plastic and stainless steel, and about a day on cardboard. All Radiology and CT equipment are classified by OSHA and the CDC as non-critical surfaces for disinfecting, contacting intact skin only (in the absence of open wounds, surgery or trauma).  This includes the gantry, padding, bore, cassette, and portable x-ray machines.  Long-handled sponges have been used to clean CT/MRI bores.

Right now there is no cleaning agent of choice for COVID.
Surfaces can be decontaminated by intermediate level disinfectants (bleach,
isopropyl alcohol, various commercial preparations) or low-level disinfectants
(any intermediate solution used < 10 minutes; ammonium solution). Intermediate
level disinfectants typically kill more viruses than low-level disinfectants. You’re
probably already using one right now!  Ask
facilities engineering or housekeeping for your institutions preferred cleaner.

Common sense would suggest that all non-critical equipment, including cleaning supplies, are put away in cabinetry or outside of the room and no open boxes, etc., are on countertops or floors. Previous recommendations made during SARS were to pay attention to cleaning frequently touched surfaces, remove unnecessary supplies and equipment to facilitate frequent cleaning, and avoid carpets if possible, vacuuming daily while in PPE if not.

Discussion:

A fear in pandemics is the overwhelming of hospital system capacity by the infected.  As a single confirmed COVID patient can take down a CT or MR suite for anywhere between 1 and 3 hours, depending on whether they are ventilated, this is a reasonable concern. The rate-limiting step in minimizing downtime and enhancing throughput will be air exchange. The following common-sense suggestions may be helpful:

First and foremost, PCR is the test of choice for COVID
diagnosis. ‘R/O COVID’ using CT is not encouraged.

Second, a lot of information can be obtained by a portable chest
x-ray. Portable chests need not worry about room gas exchange and can increase
diagnostic confidence.  They can even be
performed through glass!

Third, for facilities that have multiple CT scanning suites,
consider reserving one for confirmed positive COVID cases and another for
non-COVID patients presenting for other reasons (trauma, RLQ pain, stroke).
Institutions with multiple scanners can allocate dynamically to COVID positive
vs. negative patients based upon daily census and incidence.

Fourth, increasing throughput in the scanners dedicated to COVID
patients is challenging particularly when ventilated patients are scanned.
Scanning ventilated COVID patients in the same scanner back-to-back may not
increase risk to patients, but instead expose HCP’s to sustained droplet
aerosols with high viral titers, increasing the risk of HCP infection. Fitted
full-face respirators should be given to these HCPs. Room air flow can be
increased to clear particles more quickly by portable Negative Pressure Devices
(NPDs) – essentially portable blowers – which increase room air flow (Q), and
thus ACH.  Such devices need to be used
properly, and optimally are vented outside the building to an area 25 feet away
from public access or air intakes.¹⁸ Facilities engineering needs to
be involved in their use.  It is
conceivable that by using one of these devices with proper exhaust and a
dedicated cleaner on-site with a one-minute certified cleaning agent, three
scans an hour could be attempted – see figure 3

Figure
3 – CT patients and estimated TATs

(estimated
only)

Patient	Scan Time	Air Exchange Time	Cleaning Time	Total Turnaround Time (TAT)
Non-COVID ‘r/o bleed’	5 minutes	N/A	10 minutes	15 minutes
Suspected COVID CT chest	5 minutes	46 minutes	10 minutes	61 minutes
COVID + on Ventilator	5 minutes	180 minutes	10 minutes	195 minutes
COVID + CT Chest with NPD*	5 minutes	15 minutes	10 minutes	30 minutes
COVID + CT Chest with NPD* and 1min cleaning solution	5 minutes	15 minutes	1 minute	21 minutes

*NPD = negative pressure device

Fifth, much elective or non-urgent follow-up care has been
temporarily curtailed to create reserve capacity if a potential surge in
infections manifests.  However,
eventually those patients will need their follow-up care. It may be
preferential to shift routine imaging to outpatient facility scanners except
for chest and thorax imaging, which can be scheduled in the hospital – in order
to avoid the inadvertent identification of pulmonary ground-glass opacities at
the outpatient facility. That would likely prompt an hour-plus long shutdown
and cleaning & perhaps the closure of the facility for the day.
Alternatively, in the hospital, the patient then can be guided for PCR testing
(if appropriate) and cleaning can be done by an experienced staff with full PPE
who will be less likely to self-infect. 

The number of outpatient imaging studies performed needs to be carefully coordinated with local hospital capacity, as an unexpected finding may then prompt hospital presentation, theoretically increasing the patient’s risk of infection and further straining limited hospital resources.  A flowchart illustrating one possible decision rationale is shown in Figure 4:

As we are in the early days of the COVID pandemic, the preceding is only a list of suggestions based upon the best available data at this time.  These should be tailored to the specific needs of the individual radiologist and their facility. While CT scan and portable chest x-ray were examples, these recommendations would generally apply to ANY diagnostic imaging modality or treatment room involved in the care of COVID patients. As other patient care areas are designed with different baseline air flow rates, the CDC’s guidelines for environmental infection control, including Appendix B can be helpful for those specific areas.

Stephen M Borstelmann MD is an interventional radiologist and published medical AI researcher/speaker with an interest in operations.  

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