Ascending the Covid-19 Incline—Reform, Reaction and The Long Way Back

Ascending the Covid-19 Incline—Reform, Reaction and The Long Way Back

Confronting the unimaginable: Covid-19, a surmountable challenge

Each day as I get up and go to work, I have to prepare myself mentally in a way that I have never experienced in my 12 years as a UK Doctor. My colleagues and I witness daily, the gravity and devastation that this despicable thief of life has caused—and it is heart-breaking.

Many of us have been personally affected, directly or indirectly by Covid-19 or have lost someone we love and it is nothing short of brutal. There is no doubt in my mind that we will one day all be living in a post-pandemic world that will no longer resemble much of our pre-pandemic one either economically or socially, but I do hold the firm belief that we will once again, reclaim our independent lives, albeit in some alternate form, at the end of this war.

Adapting to the New Normal

Many healthcare professionals share the same concerns and uncertainty as the rest of the public, but in the thick of it as we are now, our primary resolve is to fire-fight our way to global safety.  

Some healthcare professionals also share the cynicism that many members of the public express about the way our various governments have handled certain aspects of this Covid-19 war. It is undeniable that many positive strategic steps have been taken, such as the rapid deployment and reinstatement of retired healthcare workers, the Herculean effort of everyone involved in the development of the UK Nightingale ITU hospitals – massive temporary hospitals put together in a matter of days to help increase capacity where regular hospitals struggle to admit any more patients – and the active campaign to protect the NHS and global health systems aimed at ‘flattening the curve’ through staying at home, to save lives, have all been pivotal and impressive. However, crucial delays in implementing a hard lockdown, PPE shortages for frontline staff, inadequate levels of testing and the procurement of antibody kits which fail to meet trialled standards have all been hot topics of debate amongst health professionals and our society at large. In response to this, I believe we will see some very significant reforms to our post-pandemic healthcare systems, striking changes within our economy and alterations in our social behaviours that are likely to be long-standing.

Lockdown V Liberty 

My colleagues and patients regularly ask my views on our current state of lockdown. The essential  move to severely curb movement amongst the population has been a globally challenging phenomenon, taking its toll financially, physically and emotionally on every individual. It is, however, the only measure that has been shown to reduce the spread of this highly contagious virus as it clearly deprives Covid-19 of the opportunity to pass from person to person. Hard lockdown has been, and still is, a fundamental step in our fight at the coal face of this pandemic but I am not convinced it can continue in its current form until a vaccine or treatment is established. The impact on the physical and mental health of the population and the socio-economic consequences of a long-term hard lockdown would likely be extensive and far-reaching. The evidence requires detailed evaluation in an effort to find a safe and workable balance in the months ahead.

This does not mean lockdown should be lifted at this phase, while death rates continue on an incline, without careful consideration as to how this should happen. If we are too impatient and take action prematurely, this would put us firmly back to square one, if not worse, as saturation points start to be reached within our hospitals. There is an infectivity index (R0), which measures how infective the virus is among people- our aim is to see this become R0 <1, which is what containment and staying at home should achieve and has been successfully reached in many countries. Anything above R0 >1 will result in an exponential growth in case numbers and this would be catastrophic. 

So, what happens after lockdown is slowly lifted? My view is that Covid-19 will continue to exist among us but we will likely step down the ladder from a pandemic state —> epidemic —> virulence levels. We will still be at risk but the probability of contracting this virus will be much lower as the number of cases declines through isolation and social distancing and we would need to exercise sensible limitations to our movements until such a time that the vaccine and treatments emerge.

If the lockdown release is too abrupt, we risk a secondary surge in cases similar to that seen in China last week in its northern borders with Russia – this was thought to be due to an influx of  overseas Covid-19 positive people into China, after which the border was quickly closed and further quarantining was mandated.

I agree with those who express the view that this pandemic will have a permanent effect on general social behaviours.  Personally, I believe there is likely to (or at least should)  be a graded exposure back to mobilising the public to essential activities first, then close family mixing and finally, over time, a more full social interaction.

It is hard to imagine that our social landscapes will ever see the dense aggregation of people that we have previously enjoyed and indeed I suspect that concerts, cinemas and even restaurants that can’t maintain safe social distancing may well need to wait for their lockdowns to be lifted until such a time that vaccines and treatments are more established. This all remains uncertain for now and the coming weeks will be telling as government strategists look at ways to safely rehabilitate us back to our functional lives. 

Collateral Damage—the Forgotten Victims of Covid-19

There is a growing concern amongst healthcare professionals that there is a risk of declining health in non-Covid-19 patients who suffer from other chronic conditions which have been eclipsed by this  pandemic. The fear is that there will be significant consequences if these patients cannot access their healthcare providers or are fearful of attending hospitals over prolonged periods of time. Patients shielding (where extremely vulnerable individuals are advised to minimise all interactions with others and stay home while having access to priority food supplies and other vital services), limited access to health services resulting from Covid-19 surges, cancelled procedures and treatments, delayed presentation and non-surveillance of chronic health conditions will all contribute to the mass grave of the Covid-19 era. 

As primary healthcare providers, we are still able to see many patients (albeit mainly virtually) but access to all our patients needs to improve to prevent an increase in non-Covid-19 mortality over time. Primary care has been forced to digitise at an unprecedented speed with the rapid scale-up and introduction of telemedicine through the use of video consulting, electronic prescribing and other digital applications that enable a more flexible remote working capability. What we can see is an enabled primary care provider that can continue to offer access and services virtually so as to minimise the risk to both healthcare professionals and patients during the pandemic The NHS and private sectors have also harmonised in an unprecedented way with private hospitals and clinics committing their facilities, staff and equipment for the use of NHS patients  Together, they have shown some impressive resolve and flexibility, which will hopefully outlive this viral war and improve national healthcare well after it no longer faces such a colossal challenge. 

Reviving the Economy—the healthcare implications

Our economy will need some serious attention in the coming weeks, not least because at a critical point, and once infectivity is R0<1, the non-Covid 19-related morbidity and mortality caused by a long-term and deep financial depression in our country may potentially outweigh the risk of Covid-19 related tragedies at that junction.

This is a veiled outcome for us all to imagine from where we are all at now but there has been considerable modelling based on Wuhan data and other research to identify the most appropriate way back to some socio-economic ‘life’. One study in the Lancet by Prem, Lui et al. highlights a number of approaches that are being trialled to achieve a return to graded social mixing and with the aim of enabling some socio-economic recovery. They acknowledge their modelling needs further research and analysis but their projections suggest that premature and sudden lifting of interventions could lead to an earlier secondary peak, which could be flattened by relaxing the interventions more gradually

So, to avoid the risk of provoking a second wave of the virus spreading, and a subsequent early second peak, we may need to be prepared to accept a relatively slow approach to lifting the lockdown.

The Marathon, not the Sprint—Uniting for the Win

No one knows how Covid-19 behaves in the long term – we just do not have that insight but an immense amount of research is being undertaken globally and each day we are more informed, more empowered and ever closer to overcoming this pandemic. For now, however, it remains an elusive and unpredictable nemesis. 

I know patience is being tested and it feels like nothing will be the same again but we should try to accept that we are in this for the medium term at least and that we may well emerge with a few positive reflections and adjusted ways of living that, while may not be the same, will still enable us to have our capacitated lives back.

In the meantime, I should say that every single health professional, researcher, and key worker I have encountered has been beyond dedicated and committed to helping us all out of this with the least possible number of casualties and, whatever our political or personal views, for now we are fully united in our fight to shepherd our nations up the incline, to the summit and down the other side safely.

Thank you To All Our Healthcare Colleagues on The Front Line

Please know that I, and many of my colleagues are deeply affected by what we are seeing each day at work, horrified at how unrelenting and unkind this criminal virus is and humbled by seeing other colleagues fearlessly approach the most risky of situations without a second thought to their own safety in order to help someone else. I am optimistic and hopeful that if every person does their bit, people stay at home and give us the time we need,  we will be able to emerge from this and hopefully have some answers. 

I want to express deep gratitude to everyone who is fighting the good fight and sympathy for anyone who has been affected directly or indirectly, or who has lost someone they love to the horror of this disease. Every single person who is staying at home for us, is a warrior in this war.

Ascending the Covid-19 Incline—Reform, Reaction and The Long Way Back 1

Dr. Rasha Gadelrab

MDisrupt Guest Blogger: Dr. Rasha Gadelrab, MRCGP MBBS BSc (Hons), NHS GP & Chief Medical Relations Officer

Dr. Rasha Gadelrab is a portfolio NHS GP, Quality Improvement Manager and a clinical Covid-19 contingency lead in a North London Practice. She is also the Chief Medical Relations Officer of www.myhealthspecialist.com. Since completing her medical training, she has dedicated her career portfolio to clinical medicine, medical education, digital innovation and healthcare quality improvement activities in order to improve patient care.

If you are a health tech founder looking for guidance on building or growing a healthcare savvy product team, talk to us—we can help.

How Healthcare and Healthtech Should Unite to Combat the COVID-19 Crisis

How Healthcare and Healthtech Should Unite to Combat the COVID-19 Crisis

We’re facing unprecedented times as we gear up to confront the reality of COVID-19, both on the economy and within the healthcare system. As cases continue to rise, sorting through misinformation on the virus has become more vital than ever. Fortunately, the healthtech and healthcare industries have never been ones to stand immobile or on the sidelines when the public’s health is at risk. With each passing day, great steps have been made to better inform the public of actionable recommendations they can make to combat the growing COVID-19 crisis, including a passionate movement to increase efforts on the current and most significant challenge: production and distribution of clinically valid diagnostic tests.

And with the current climate, anxiety and trepidation abound showing an uptick in claims surrounding the coronavirus pathogen. There is no more prevalent time for rapid dissemination of scientifically valid research to help educate and appease the public than now. With more people staying at home and practicing “social distancing,” the market has become a flooded landscape of companies either suffering or taking advantage of nervous individuals. Although there is an opportunity to help stabilize the health market, the greatest potential is in partnering tech with patient care to promote evidence-based information and valid actionable recommendations to the many facing the COVID-19 pandemic. 

The first step is understanding  which are some of the most reliable resources available – which include more than constantly refreshing the CDC website – in fact, the CDC provides a variety of webinars to address updates for private sector partners, including frequently asked questions about the virus.

In addition, several credible sites ranging from OSHA to the New York Department of Health are regularly updated, sharing protective tips and FAQs. If you’ve recently reviewed the USDA’s response or visited the WHO’s website, you’ll find similar levels of information. But as the government continues to struggle over the shortage of diagnostic tests and the stresses facing the healthcare system, new opportunities are emerging.

How Healthcare and Healthtech Companies Have Risen to the Challenge

The healthcare and healthtech industries have responded to the call for increased action to combat COVID-19 across various fronts. This has taken the form of amplified production of kits, reagents and supplies, therapies, and preventative-care products. We’ve seen many companies rise to the occasion to address the severity of gaps in COVID-19 preparations. 

Test Kit Suppliers 

Building a health product responsibly takes careful orchestration between medical, commercial and regulatory teams and can often take years for commercialization and scale.  However in response to the crisis, the FDA has expedited the process to approve new COVID-19 kits under the new Emergency Use Authorization (EUA) guidelines. This has allowed a number of health companies to quickly mobilize and create tests that have made it to market in a matter of weeks

The severity of the situation has since been emphasized as the CDC has announced the allowance of commercial testing facilities to develop and distribute COVID-19 tests as of February 29th – with companies like Thermo Fisher offering state-of-the-art pathogen detection kits for both real-time PCR and Applied Biosystems QuantStudio 5 assay systems. As the CDC has repeatedly announced their challenges in improving the availability of tests, Thermo Fisher’s increased production is alleviating the scarcity in kit supplies. 

Several other companies have also  developed current COVID-19 test kits and begun making them more accessible to meet the growing and urgent demand.  Their quick response has steadily reduced kit shortages. This list of companies grows each day and includes: 

In recent weeks, Cepheid has released a COVID-19 test with an analysis 4x faster than standard kits with an improved 45 minute turnaround. Their test, now available, has been primarily distributed to hospitals first. 

Reagent Suppliers

As the COVID-19 crisis has grown, demand for reagents and testing supplies has surged. Fortunately, companies such as Promega manufacturers have answered the call of the CDC in improving access to critical components needed for diagnostic test production. Already, Promega has begun accessing their stored inventory and ramping up production of the key materials and reagents necessary for meeting the demand of diagnostic tests. Their focus has meant fulfilling much-needed orders by adding additional work shifts, paying overtime, and even diverting work on other projects to prioritize COVID-19 efforts. Reagent supplied Qiagen has also joined its ranks, aiming to increase its contribution 4-fold.

Monitoring and Screening 

In an effort to better monitor changes in COVID-19 progression, technology companies such as Alibaba have developed open-source platforms that update in real-time. They’re joined by other platforms supported by Johns Hopkins COVID-19 Global Dashboard and Bing’s COVID-19 Tracker. With the private sector quickly responding to the gaps by the public sector, we’re seeing market-driven innovation that’s improving the general public’s access to reliable information.

For example, a quick review of commonly searched keywords shows an increase in symptom checks, adding to the current pitfalls in amatuer diagnostics. However, leading innovators like Buoy Health have worked to develop a systematic online screening tool that rapidly assesses symptoms related to COVID-19, alongside the Cleveland Clinic’s. Their tool arrived shortly ahead of Apple’s symptom triage tool, featuring a CDC-approved symptom flow within Siri voice assistant

Telemedicine

While historically the healthcare world has been slow to adopt telemedicine, the COVID-19 crisis has shone a light on the benefits of remote medicine during contagious pandemics. Telemedicine has now become a key tool enabling the public to maintain social distancing practices while still accessing healthcare. This has been facilitated by the Trump Administration’s initiative to expand CMS’s telehealth accessibility. For individuals looking for online resources, you can also access Doctor on Demand, featuring an online symptom assessment.

Medical Equipment and Supplies

Health and tech companies have also responded to help with delivering preventative measures.  With healthcare professionals on the frontlines in our hospitals and doctor’s offices, we’re seeing mass shortages of personal protective equipment, or PPE, as large quantities of protective masks have been purchased by the anxious public. Although most low-grade masks work best for those already ill, the N95 respirators and surgical masks shown to protect against airborne particles are in low supply. Earlier this month, Jack Ma of Alibaba has also improved availability and distribution of N95 masks by pledging to send 1.8 million masks to Asia, which has since been expanded to Africa, Europe and the U.S. including protective suits, ventilators and thermometers.  

Additionally, to improve funding, Biogen has also donated $10 Million to non-profit organizations working during the crisis, including donating medical equipment to supplies to Partners HealthCare in Massachusetts and local hospitals.

Clinical Trials and Therapeutic Development

Other government efforts  to develop treatment options for severe cases have teamed up with pharmaceutical company Roche. Currently, their arthritis drug Actemra has already been in use by Chinese authorities to address COVID-19 cases, however the need for establishing clinical validity is pressing. To tackle the feasibility, the FDA has partnered with Roche to initiate a randomized, double-blind, placebo-controlled phase 3 clinical trial to study Actemra for patients hospitalized with severe COVID-19 induced pneumonia. This comes on the heels of Japanese drug Favipravir, used to combat the flu, which has been shown to be effective in treatment in both Japan and China after a series of clinical trials with over 340 patients. However, the Japanese health ministry has stated that its efficacy is reduced in severe cases and would require government approval before it can be used to treat COVID-19 cases.

The greatest challenge for potential treatments remains the time necessary for evidence generation to assess the safety and efficacy – though we’ve seen various pharmaceutical companies announcing breakthroughs in their viral research efforts (such as companies like Regeneron, and drugs such as Chloroquine). During this time it can seem like grasping for straws may give the appearance of progress, but devotion to clinical validity is the only way to halt the progression of the viral pathogen. Various companies, such as Benchling, have donated funds and resources to research labs working to develop diagnostics, vaccines, and treatments. Reify Health has also begun offering funding for companies utilizing clinical trials for COVID-19 therapies and treatments.

Healthcare and Healthtech Can Make A Difference Together.

Desperate times call for more collaboration and uniting industries to bring together skills to solve health problems both quickly and responsibly.  Despite the urgency health companies feel to bring products to market quickly, it’s important not to take shortcuts in evidence generation so that products are proven to work and are safe.  Healthtech companies have the advantage of technology and agility. Healthcare experts understand how to build medically viable products and navigate the regulatory path. The most critical thing a healthtech company can do is engage health industry experts early and often in the process of bringing health products to market. 

At MDisrupt, we have over 50 Health Industry experts many of whom are dedicated to offering their time and skills to assisting companies combating the COVID-19 crisis. These include physicians, regulatory and commercialization experts .  Most notably a number of pathologists in our network have offered to donate their time to provide CLIA lab medical director services to labs who need assistance. Talk to us, we want to partner with you to contribute to building solutions for this crisis together.

Combatting Misinformation related to COVID-19: a Primer for Healthtech Companies and Consumers

Combatting Misinformation related to COVID-19: a Primer for Healthtech Companies and Consumers

As a Pulmonary & Critical Care Physician who has a passion for finding digital technology solutions to our health care problems, as well as 5 years of experience helping healthtech companies in the SF Bay Area, I have evaluated many and led the adoption of several platforms in my practice.  Through involvement with Health 2.0 SF, I have mentored founders with solutions that have the ability to re-shape the practice of Medicine.  Below I share my observations on the tsunami of COVID-19 information we are deluged in.

Misinformation Avalanche

Fortunately: scientists, epidemiologists, and physicians are not facing anything new when confronting the copious amount of misinformation people bring to them.  People over the span of time, without credible background knowledge on a subject, have been prone to follow movements based on an erroneous understanding of causation vs correlation or fear-based propaganda that fits their political ideology.  The epitome might be the Anti-Vaxxing crowd, many of whom are already lining up against any possible future Coronavirus vaccine.  COVID-19 has brought upon an onslaught of media and social media activity: with the ability to spread helpful information on these channels has come an unprecedented manner to spread misinformation that at minimum confuses (what is fact vs opinion), often shapes (opinions and behaviors), and occasionally kills.

Already related to COVID-19 we have seen the home-remedy folks, conspiracy theorists, and racists rush to create fake news or propaganda to satisfy a fearful base.  To counter this deluge of bad information, Twitter, Google and Facebook are launching campaigns within their platforms to fight it back; and even CNN’s Dr. Sanjay Gupta has a new Podcast that has content to educate and combat against misinformation.  As part of the health community, please be careful what you re-tweet or share: consider the source (CDC, WHO, local hospital medical leaders are reputable), do not under-analyze preliminary scientific (typically not peer-reviewed) data, and keep in mind that certain knowledge is not concrete, as scientists continue to unravel  this disease.   Slow down and fact check!

Developing Healthtech in the World of COVID-19

Healthtech founders, including ones I mentor, are facing an existential dilemma: push forward with their platform in a badly damaged economy with fewer VC and consumer dollars; or tailor their platform to help solve a need in our current pandemic, and hope the buy-in and funding will come.

For either approach, I describe the Quadruple Aim that leaders in hospital systems need from health technology.

The Quadrupal Aim
Combatting Misinformation related to COVID-19: a Primer for Healthtech Companies and Consumers 2

Briefly, all solutions must begin by being able to either improve the patient or clinician experience.  A platform aimed at improving the experience for either patients or clinicians must lead to mutual benefit: an improved patient experience must not come with a worse clinician experience, or vice versa.  Concomitantly, a new platform that can help lower costs will only be successful by leading to improved outcomes and patient/clinician experience.  Patients will and must always come first.

It is impossible to understand the nuances of the Quadruple Aim (when considering your consumer and purchasers: patients, clinicians, hospital/government administrators) without a domain expert who understands medical affairs (your product and your consumers).  Everything within the Quadruple Aim needs to be in sync for there to be success of a new platform. 

If the solution, for example, is aimed at improving patient outcomes related to COVID-19 then this requires validation – a level of evidence that demonstrates that the data obtained from the platform is accurate, and that the added data is effective in its goal relative to doing nothing (or versus the standard of care).  The solution also must be easily integrated into the workflow, for patients to use (ex: how many smartwatches are worn consistently; asking consumers to perform manual data entry into an app is not typically sustainable) and/or for clinicians to access seamlessly.  A bad patient or clinician experience ensures a futile effort.  The process is lengthy and complicated, and it needs to be kept in mind that each particular locality will have variable needs during this pandemic.  Talk to medical professionals near you with boots on the ground.  If it will take over a year to perform a fast-tracked clinical trial on a vaccine and therapies, and until March 21st to see Google create its Coronavirus resources; then it will take time even for a digital platform to apply the scientific method to identify the problem within the pandemic to solve, and then testing of the platform for meaningful outcomes.

It Takes a Village

What is not misinformation is that with every known major societal disruption there are opportunities that rise through the ashes and lead to fundamental change.  There are multiple areas impacted by COVID-19 that need solutions, including the supply chain, population management, consumer facing tools, and back-office.  When tailoring a platform to meet the needs of our Coronavirus pandemic, an honest assessment must be first made of whether anyone on the team has experience in epidemiology, pulmonary, and/or infectious diseases.  Product development and management in Tech requires a different skillset and experience base than for Health. There are no short cuts for understanding the disease; or clinician and patient behaviors, attitudes, and needs. You will need a team, including domain experts and experienced healthcare product managers: talk to us, we are here to help.

Combatting Misinformation related to COVID-19: a Primer for Healthtech Companies and Consumers 3

Sachin Gupta MD, FCCP, ATSF, Physician Consultant

MDisrupt Guest Author

Dr. Gupta is a thought leader in Healthtech and a Consultant through his roles previously at Kaiser Permanente and Health 2.0 SF, where he co-developed the “Project Zygote” pre-accelerator curriculum for entrepreneurs in digital health. Clinically he is in private practice now and a known expert in rare lung diseases, early technology adopter, and patient advocate. He is an editor for the monthly California Thoracic Society Inspirations, as well as the CHEST Physician newsletters, and an active member of the Pulmonary Hypertension Association.

Specialties: Pulmonary, Critical Care, Clinical trials, Digital Medicine, Rare lung disease, Physician education, Patient education, Medical Affairs.

If you are a health tech founder looking for guidance on building or growing a healthcare savvy product team, talk to us—we can help.

Put the Health Back in Healthtech: A Product Manager’s Perspective

Put the Health Back in Healthtech: A Product Manager’s Perspective

Build a healthcare-savvy team; build successful healthtech products

Good healthtech products are really hard to build. Every year healthtech attracts great technologists who have had personal experiences with the broken healthcare system. And yet, along with myriad silent disappearances, there are publicly reported flops in healthtech from scrappy start-ups and tech giants alike. What are some of the common pitfalls? And what can your company do to safeguard against them?

Map the players – patients, providers and payors – and understand their motivations

61% of digital health companies that start B2C end up pivoting to B2B and selling to insurance companies, employers, hospitals, or other healthcare providers. Some of this strategy change is natural growth – healthtech companies pilot by selling directly to consumers, and then gain traction and bigger partnerships. But many healthtech companies shift to B2B selling after gaining a hard-earned understanding of the healthcare ecosystem from some time in the field.

We’re all familiar with the patient-provider-payor dance in healthcare. Your company is (likely) trying to improve the health outcomes of the patient, whilst also delighting the provider, who bills your payor. Unlike in many commercial technology businesses, where customer usage and retention tells you a good story about the value of your product, the feedback loop in healthtech is more opaque given this complex tri-partite structure.

One way to minimize the swirl created by this fuzzy feedback is to map your patient, provider and payor stakeholder groups. If you like graphical tools, this might be useful. With each group, identify:

  • What success looks like. Simple phrases about each stakeholder, “Make it easy for the provider to pay for our screening test” can turn into company initiatives, which in turn can be used to guide product roadmaps.
  • How stakeholder incentives are aligned with this vision of success
  • How stakeholder incentives are not aligned
  • 3 most-likely failure modes

This exercise (hopefully) doesn’t pivot your direction, but instead helps clarify where you have dark or blind spots. Re-do the stakeholder exercise quarterly or twice a year to ensure alignment between your roadmap and the healthcare ecosystem.

Understand governance, risk management & compliance (or know when to ask for help)

Healthcare is a regulated industry. Depending on your company’s specialization, if you run a lab, you’ll be working with CLIA requirements; if you’re building medical devices, you’ll be working with the FDA, etc. These efforts require specialized dedicated resources. Additionally, almost all healthtech companies will be working with HIPAA protected data. Healthcare data is a hot topic today, including everything from massive data breaches to data-landgrabbing.

Product teams have to account for data compliance in your product strategy, design and implementation cycles. Basics & resources on HIPAA that product teams should know about include:

  • Various public cloud solutions now have HIPAA compliant offerings, including  Amazon Web Services, TrueVault, Aptible & ClearDATA
  • Remember HIPAA is more than technology – the regulations include incident response, risk assessment, operations management, policies & procedures and security & compliance. Training is required for anyone handling Protected Health Information (PHI). Compliance cloud platforms can help you manage this & the associated auditing: Reciprocity Labs, Aptible & ClearDATA
  • Your product managers (as well as your engineers) should be familiar with these HIPAA dev resources published by HHS

Establishing and maintaining trust in your healthtech product offering is core to your success. Give your teams the time and resources to manage the regulated aspects of the product in the right way, and save the headlines for your victories, not compliance violations

Pay extra attention to the seams

So you’ve built a beta release. Now for testing! Health problems are deeply human, and therefore the software solution workflow is embedded in a complex, multi-layered context: the real world. This is the zone in which healthtech products most often fail. Successful healthtech products are 1) integrated into the user’s workflow – and sometimes two or more stakeholders are users, and 2) interoperable with existing software or hardware solutions.

  • Test early. Get your software into the users hands for feedback as soon as you can. Reid Hoffman famously said “If you’re not embarrassed by your first release, you’ve waited too long to ship.” In healthtech it is important to contextualize these early releases carefully – e.g. make it explicit to friendly users or pseudo-users that this release is for feedback only; ask if you can demo live and shadow them in their workflow to see how they use the product etc.
  • When doing customer research and gathering feedback, explicitly ask about the various usage contexts for different users. Pay close attention to what other software or hardware your solution needs to interoperate with to minimize friction. Try to understand what happens if workflow integration and interoperability doesn’t happen – it’ll help you prioritize, and more quickly understand your larger scale usage data later on
  • Articulate priorities around integration and interoperability to get a clearly prioritized roadmap, plus decision documentation. A useful tool for this is MSCW prioritization.

Real world usage context is a challenge for any software development effort. It is even more critical in the world of healthcare which includes high stakes decisions, quirky and complex workflows in a time-scarce environment. Elegant integration & interoperability will beat fancy features anytime.

There are lies, damned lies & statistics. Be rigorous.

There are often two types of evidence generated and used by healthtech companies – marketing data and clinical evidence. Marketing data is used to quantitatively describe the benefits of the product. These results must be real and attained through rigorous analysis, however they have not been achieved in a clinical trial setting. Clinical evidence is generated by running an experiment (the gold standard is a randomized controlled trial, but there are various other methods) which is designed to test the protocol’s impact on the intended outcome given a controlled context. Your product teams must understand the differences between these types of information, and communicate results clearly throughout the organization to avoid confusion around data claims.

Most healthtech products that are aspiring to be paid for by insurance companies will likely need to run a clinical evidence effort at some point. Get your team ready for this by familiarizing them with scientific writing. It’ll also keep them current on the medical research in your product area. Some resources:

  • Stanford uses this paper to teach to students the basics of academic reading
  • How to read a Clinical Trial provides an overview of how to interpret evaluate a clinical trial, and provides context on the statistical rigor involved in generating clinical evidence
  • Bradford Hill Criteria provides a great framework for unpacking the logical consistency of a clinical trial

These are good tactics for building a rigorous culture of scientific literacy in your product teams. Deepest expertise in this area, will come from team members with degrees focused in epidemiology, e.g. Masters of Public Health (MPH), or MS in Epidemiology and Clinical Research etc.

We all know healthcare is broken and we believe in the power of healthtech improve our lives. Understanding the complex healthcare ecosystem, accounting for governance requirements, thoughtfully developing for real-life user workflows and establishing a culture of scientific rigor will help you change healthcare for the better, ultimately both faster & stronger.

Put the Health Back in Healthtech: A Product Manager's Perspective 4

Elizabeth Brook Garrity

MDisrupt Guest Author

Elizabeth is a product manager with experience developing machine learning software-as-a-service. She developed her healthcare chops as a program manager at at UCSF, and at Dartmouth’s Masters of Public Health program. She started her career as a management consultant, after graduating from Harvard.

If you are a health tech founder looking for guidance on building or growing a healthcare savvy product team, talk to us—we can help.

Understanding Medical Necessity: Guidance for Healthtech Companies to Address Medical Insurance Coverage Limitations

Understanding Medical Necessity: Guidance for Healthtech Companies to Address Medical Insurance Coverage Limitations

Many healthtech companies want to access the self-insured employer market.  In my previous blog, How Healthtech Companies Can Successfully Access the Self-Insured Employer Market I highlighted the important factors that healthtech companies need to consider when accessing this channel.  Many companies focus on this channel as a way to commercialize and drive adoption before their product is reimbursed by a health insurance plan.

The goal of this blog is to help you understand some of the key definitions that are important to understand in this channel and the process by which decisions are made.

Let’s get familiar with the important definitions: 

  • Self-Insured Employers: While the risk falls on the insurance company in a fully insured plan, in a self-insured plan the employer or company assumes most of the risk. Businesses that have self-insured plans must pay for employee medical claims and associated fees from their own general assets. Larger employers tend to be self-insured. The percentage of medium and smaller companies that self-insure is growing significantly.
  • Insurance Company: A company that offers health plans to customers. These can also be known as medical insurance companies or health insurance carriers.
  • Health Plan: A health insurance policy with defined benefits coverage. An employer can offer several health plans, from one or several health insurance companies.
  • Benefits Coverage: Defines both the dollar amounts of coverage (i.e., contributions, deductibles and copays) and the medical services covered.
  • Medical Necessity: A determination as to whether and when a medical service should be covered (paid for) by the insurance company.
  • Clinical Policy: A written document containing the clinical rationale for medical necessity determinations for a particular medical treatment or diagnostic.

Now that we understand the terms, let’s get back to the central conundrum that new healthtech companies face: 

“Why should I pay for this if it isn’t covered by the insurance company?”

In other words, If an employer’s medical insurance company doesn’t cover a diagnostic or therapeutic service, why should the employer consider buying it separately?

The answer is found in the corridor between “medical necessity” and what can be argued is genuinely “medically necessary.”  In order to prove that your product/service is medically necessary, you first need to understand the medical insurance company’s medical necessity policies for your technology.

Medical Necessity: Health Plan Clinical Policies

As defined above, medical necessity is the process for determining benefits coverage and/or provider payment for services, tests or procedures that are medically appropriate and cost-effective. 

Some policies may be developed internally, some externally. Most medical insurance companies maintain a clinical policy unit of internal and external clinical advisors that apply their own process of medical diligence which includes: 

  • Regularly monitoring new treatment, technologies and indications

  • Reviewing new treatments submitted for coverage

  • Searching the National Library of Medicine’s PubMed database of peer-reviewed medical literature

  • Assessing regulatory statutes of new technologies (e.g., FDA)

  • Reviewing evidence-based clinical practice guidelines, such as the Agency for Healthcare Research and Quality’s (AHRQ) National Guideline Clearinghouse database

  • Reviewing recommendations of national medical societies and their guidelines.

  • Considering the indications accepted by the USP DI (United States Pharmacopeia-Drug Information) and ASHP (American Society of Health-System Pharmacists) for drug treatments

  • Assessing the opinions of relevant experts where necessary.

As described in my previous blog, most employers have insurance companies, or some other plan administrator, process medical claims. These insurance companies and administrators abide by a set of clinical policies around medical necessity established by the clinical policy unit(s). These policies apply these criteria for assessing a service, test or procedure:

  • Is it in accordance with generally accepted standards of medical practice?

  • Is it clinically appropriate and effective?

  • Is it not primarily for convenience?

  • Is it not more costly than an equivalent alternative service?

  • Is it endorsed or recommended by national medical societies and associations?

  • The technology must have final approval from the appropriate governmental regulatory bodies, when required. FDA approval, where applicable, is necessary but not sufficient to meet coverage criteria.

  • Medical insurance companies are not obligated to follow Medicare policy for their commercial members. Medicare coverage policy is often considered, however, in formulating clinical policies for commercial plans.

Medical necessity determinations arise most commonly where the service requested is subject to pre-authorization procedures. Here are some of the most common categories for pre-authorization:

Frequently Required Pre-Authorizations

Understanding Medical Necessity: Guidance for Healthtech Companies to Address Medical Insurance Coverage Limitations 5

The challenge, then, is how a healthtech company justifies the cost of the new service in light of the medical insurance company’s clinical policy. In order to do that, a healthtech company needs to understand what the clinical policy language is for medical insurance companies,recognizing that they can often vary.  In some cases, levels or degrees of coverage (including frequency, duration, pre-authorization requirements) may vary based on group plan design. Examples include: number of allowed physical therapy visits, coverage for alternative treatments such as acupuncture, and length of stay for substance abuse rehab.

Each policy includes: 

  • Coverage rationale that includes the scope of the decisions rendered, as well as their context

  • Documentation requirements for treating providers

  • Definitions of terms used in the policy

  • Applicable codes including CPT (medical procedures) and ICD10 (medical diagnosis) codes 

  • Description of services, e.g. a more complete review of when and how the services addressed shall be treated

  • Clinical evidence including a discussion of major studies, guidelines and other research used to craft the decision. These are defined here in the blog The Formula for Widespread Adoption of health Products that Every Investor and Healthtech Entrepreneur Needs to Know.

  • US Food and Drug Administration status, including relevant approvals from the FDA

  • Centers For Medicare And Medicaid Services status, including relevant information about what Medicare and Medicaid typically cover in the area addressed

  • References e.g. a useful bibliography for healthtech companies

  • Policy history/revision information e.g. a review of previous iterations of the current policy

  • Instructions for use e.g. a description of how the medical insurance company administers the policy.

Depending on the type of service, some healthtech companies may directly pursue the insurance companies. In most cases, however, marketing healthtech services directly to the self-insured employer should include a rationale as to why the covering insurance company does not cover the product or service.

Clinical policies can also be leveraged to identify what sources are used to establish the relevant clinical policy. The sources include: individual academic studies, national medical society guidelines, federal agency criteria (such as the FDA), federal institute guidelines (such as the CDC and the NIH), specialty and subspecialty medical colleges and organizations, and a fair number of others. These materials may be useful to make the case for your product or service.

Examples of Medical Insurance Company Clinical Policies:

For purposes of illustration, the following is a small subset of some of the clinical policies published by United Healthcare in a single year period.

Understanding Medical Necessity: Guidance for Healthtech Companies to Address Medical Insurance Coverage Limitations 6

Key Points For HealthTech Founders

  • Healthtech companies need to understand how health insurance companies define medical necessity in order to make the case for the solution they are bringing to the self-insured employer.

  • Medical necessity defines what is covered by a health insurance plan in a general population. That definition is intended to protect the self-insured employer and its covered members from paying for medical services that are excessive, cost-inefficient, or not clinically warranted. 

  • The opportunities for healthtech companies looking to directly reach self-insured employers lie in making the case for the business value of the solutions offered. 

Medical Necessity: Finding the Leading Edge, Avoiding the Bleeding Edge

In my next blog post, we will examine how healthtech companies can make the case for medically necessity even when an employer’s health plan does not cover the service. 

This includes addressing the following questions: 

  • What are the major reasons that a new approach should be covered even when the medical insurance company doesn’t cover it?
  • What advantages does your approach have (i.e., selection of appropriate members, place of service, etc.) that are not currently in place that can help maximize the return of investment for the service?
  • Why should an employer proactively include this service and pay for it above and beyond what is covered by the medical insurance company?
  • Will the service bypass, reduce, pre-empt or help avoid other costs incurred by the employer’s health plan?
Understanding Medical Necessity: Guidance for Healthtech Companies to Address Medical Insurance Coverage Limitations 7

Ronald S. Leopold, MD, MBA, MPH, Physician Consultant

MDisrupt Guest Blogger Specializing in Employee Benefits, Medical Cost Solutions, New Medical Technology

As a credentialed and experienced professional, Dr. Leopold brings credibility and a breadth of knowledge as a consultant, client advocate, and marketplace spokesperson. He is an industry thought leader in employee benefits and health and productivity.

Specialties: Medical Costs, High Cost Claimants, New Medical Technologies, Employee Benefits, Heath and Productivity, Population Health Data Analytics, Global Workforce, Generations in the Workforce, Financial Wellness, Thought Leadership, Public Speaking.

Accessing the self-insured employer channel correctly takes special expertise. If this channel is key to your commercial strategy, talk to us—we can help.