Ouchie , a Chronic Pain Management App Mapping “Pain Journeys” | Rachel Trobman, Upside Health

BY JESSICA DAMASSA, WTF HEALTH

Not only is ‘Ouchie’ what you say when you’re in pain, but now it’s also what you say when you need to find relief! Rachel Trobman, CEO of Upside Health, introduces us to Ouchie, a remote patient monitoring and treatment tool for chronic pain that patients can download onto their phones. Central to the patient experience of the app is the focus on documenting the patient’s “pain journey” where they answer a series of important lifestyle questions that inform the platform to come up with ways to receive support and other health resources. Not only does this self-reported data help patients identify triggers and patterns that impact their pain level, but it is also a treasure trove of information for physicians who can use it to better (and more quickly) tailor treatment to suit individual needs. The business behind Ouchie, called Upside Health, is starting to take off too and Rachel talks through revenue model, funding, and future plans.

Filmed at Frontiers Health in Berlin, Germany, November 2019.

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Why the Centene and WellCare Merger is the Biggest Deal in 2020

By ANDY MYCHKOVSKY

I feel like the healthcare world just skipped over the $17.3 billion mega-merger between Centene and Wellcare, which just received final regulatory approval last Wednesday. With their powers combined, this new company will create the Thanos of government-focused health plans, hopefully without any of the deranged plans to take over the world. I do get it, 181 million lives are covered by employer-sponsored insurance, between full-risk and self-insured plans. These employer populations have the most disposable income and their HR departments are willing to provide supplemental benefits. However, in my opinion, the future growth of health insurance will be governmental programs like Medicare Advantage (MA), Medicaid managed care, and ACA exchanges. But instead of me telling you this, here is exactly what Centene and WellCare said in a press release to defend the merger:

“The combined company would be the leader in government-sponsored healthcare with increased scale and diversification both geographically and in its managed care service offerings, and enhance access to high-quality services for members. It will offer affordable and high-quality products to its more than 12 million Medicaid and approximately 5 million Medicare members (including Medicare Prescription Drug Plan), as well as individuals served in the Health Insurance Marketplace and the TRICARE program. The combined company will operate 31 NCQA accredited health plans across the country and will have increased exposure to government-sponsored healthcare solutions through WellCare’s Medicare Advantage and Medicare Prescription Drug Plans. It will also benefit from leveraging Centene’s growing position in the Health Insurance Marketplace to new markets. The transaction creates a company with the size and scale to better serve members through enhanced healthcare programs, expanded capabilities and increased investment in technology.”

Simply put, here’s some of quick stats provided at the JP Morgan Healthcare Conference presentation on January 13, 2020:

  • National footprint now serving 1 in 15 Americans
  • Clear market leader in Medicaid managed care and ACA exchange marketplace
  • Dominance serving most complex populations, #1 leader in LTSS and #2 in dual eligible
  • Competitiveness in the Medicare Advantage (MA) enrollment wars
  • $500 million in proposed savings due to annual cost synergies

Announced back in March 2019, some investor analysts questioned the merger given the significant overlap between each plan’s enrollment and focus on governmental programs. Turns out, in some states, the combined entity would have monopolistic tendencies. Therefore, in order to satisfy anti-competitive market dominance, WellCare must divest its Medicaid and Medicare Advantage plans in Missouri, Medicaid plan in Nebraska, while Centene must divest its Medicaid and Medicare Advantage plans in Illinois. So long as they comply with these specific requests, you have yourselves a ballgame folks.

I’m actually a bit shocked these few divestitures is all that is required given their combined business. For example, Florida is the 4thlargest Medicaid state in the country. This is also where WellCare is headquartered and holds the largest Medicaid managed care enrollment in the state. The combined market share between Centene and WellCare nears 46% as of December 2019 enrollment reports for the traditional Managed Medical Assistance (MMA) population (e.g., TANF, SSI, ABD) with over 2.7 million lives. Now Florida did just finish their open enrollment period in January, so there is potential that the two plan’s enrollment could’ve changed by now. However, I find it difficult to believe their enrollment would change too significantly given the relatively low open enrollment churn rates in Medicaid.

Why does this all matter? Because Medicare covers 61.2 million Americans and Medicaid covers 75.8 million Americans. That represents 137 million total lives between the two major lines of business that Centene and WellCare focus on. Add in the 8.3 million from the 2020 ACA exchanges and that is just icing on top of the cake for next decade’s growth opportunity. We have a baby boomer population (ages 52 to 70) that numbers 74 million and beginning to age into Medicare. These are the highest cost population segment, excluding some of the smaller specialty populations (e.g. PACE), that must be managed by either Medicare fee-for-service (FFS) or Medicare Advantage plans.

Let’s start with MA. I wrote an entire blog last week on the MA market, particularly from the perspective of the startup health plan. To recap, the battle for MA is hard. The sales and marketing expenses for subscale plans is high due to broker fees for initial enrollments and renewals. The plan must be old enough with good quality to receive a high Medicare STAR quality rating, which in turn requires the federal government to provide bonus payments to the MA plan that can be used to offer patient’s supplemental benefits. Given the high medical cost of MA patients, $800-1,000 per member per month (PMPM), small plans are subject to actuarial risk and higher outlier expenditures that can sink your plan’s medical loss ratio (MLR).

Let’s take Duval County, Florida, home of the Jacksonville Jaguars and 180,000 Medicare eligible beneficiaries and 70,000 MA lives (39% MA penetration rate). In this particular MA market, Centene and WellCare account for 17% of the total MA lives (~12,000 lives), trailing only UnitedHealthcare (32%) and Humana (19%). This merger nearly triples Centene’s existing MA enrollment and places them in a much better position to compete against the major for-profit incumbent and startup plans. They will still only account for 3.6% of the total MA market, but appear focused on targeting this older customer base and will benefit from the broader trends from FFS to private plans. All-in-all, Centene and WellCare have a combined 875,000 lives across 455 MA plan options as of January 2020.

Now let’s switch to Medicaid. The worst kept secret in healthcare is that Medicaid (not Medicare) is the primary payer of long-term services and support (LTSS) like nursing homes in America. If we’re projecting forward, where do you think the 74 million baby boomers are likely to reside as they age? With a shortage of qualified home health aides (not to mention how expensive out-of-pocket it can be), limited societal buy-in for multi-generational housing (compared to Asian countries), and younger generations receding to expensive, urban areas, Houston we have a problem. Not to make matters worse, but the only way for your loved one to receive Medicaid benefits to cover nursing home care, is if they’ve already used up most their savings and assets. Once they’ve hit that financial point of no return, it is unlikely your loved one will be able to afford anything else beyond the nursing home that accepts their Medicaid coverage.

In terms of growth opportunities, I mentioned in a previous Heathcare Pizza blog that majority of states have already transitioned into Medicaid managed care. Most states contract with payers like Centene or WellCare to administer the program for a portion of patients in return for a set per PMPM fee. This fee is set by third-party actuarial firms and includes the desired medical loss ratio (MLR), administrative loss ratio (ALR), and profit margin built in. The way you win a coveted contract award is by applying during a competitive request for proposal (RFP) period that typically happens every few years. Centene already has a strong 5-year Medicaid RFP win rate of 80%, and adding WellCare will only bolster their chances. With North Carolina scheduled to move into managed care in 2020, of which both Centene and WellCare were awarded separate contracts, the game is less about net new states but instead focused on transitioning all populations into managed care.

For example, the state of Arkansas is currently undergoing a process to transition their Medicaid populations into managed care via the Provider-led Arkansas Shared Savings Entities (PASSE) program. The state chose to start with the most complicated and expensive population, the ~45,000 intellectually and developmentally disabled (I/DD) patients. They started here because these patients alone cost Arkansas Medicaid over $1 billion annually. However, there are 926,000 Medicaid lives in the state as of December 2019. If you don’t think health plans like Centene see the potential opportunity to convert the remaining members into their managed care enrollment, you’re being naïve.

Up to 24 million lives will be covered by this newly merged entity, forming a formidable opponent to the dominant for-profit health plans like UnitedHealth Group and CVS / Aetna. If their go-to-market roadmap is successful, I see good things for employees and investors related to the company in the near future. That is not financial advice, just one man’s opinion. I will tell you one thing though, the market seems to have come full circle because since October 2019, the stock has been on a steady rise in preparation for the merger approval.

Andy Mychkovsky is the creator of Healthcare Pizza, where this post originally appeared. Follow him on Twitter (@AMychkovsky) and LinkedIn for future thoughts and updates.

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Livongo Takes on Hypertension | Zane Burke, CEO, Livongo

BY JESSICA DAMASSA, WTF HEALTH

Livongo CEO, Zane Burke, has been a busy guy since the company’s IPO late last year. The applied health signals company has seen triple-digit (148%) growth and a robust expansion of the weight management and behavioral health platforms they’ve been building to support the ‘whole health life’ of people with diabetes. Case-in-point, Zane talks through the outcomes of the company’s latest clinical research on Livongo’s hypertension management tool, which showed that clients who used both Livongo’s diabetes management tool and hypertension tool in tandem experienced significant decreases in their hypertensive blood pressure in as little as four weeks. As traditional healthcare companies and digital health startups alike continue to watch Livongo’s every move for an indication of ‘what’s possible’ for health tech startups, we asked Zane to clue us in on how he’s keeping his team focused on product development, market expansion, and issues related to reimbursement.

Filmed at Frontiers Health in Berlin, Germany, November 2019.

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Quantum Theory of Health

By KIM BELLARD

We’re pretty proud of
modern medicine.  We’ve accumulated a very intricate understanding of how
our body works, what can go wrong with it, and what are options are for
tinkering with it to improve its health.  We’ve got all sorts of tests,
treatments, and pills for it, with more on the way all the time.

However, there has been
increasing awareness of the impact our microbiota has on our health, and I
think modern medicine is reaching the point classical physics did when quantum
physics came along.  

Image credit: E. Edwards/JQI

Classical physics
pictured the atom as kind of a miniature solar system, with well-defined
particles revolving in definite orbits around the solid nucleus.  In
quantum physics, though, particles don’t have specific positions or exact
orbits, combine/recombine, get entangled, and pop in and out of
existence.  At the quantum level everything is kind of fuzzy, but quantum
theory itself is astoundingly predictive.  We’re fooled into thinking our
macro view of the universe is true, but our perceptions are wrong.   

So it may be with modern
medicine.  Our microbiota (including both the microbiome and mycobiome) both provide the fuzziness and dictate a significant portion of
our health.   

Two articles in Science illustrate
how we’re still just scratching our understanding of their impact. 
The first, from Rodrigo Pérez Ortega, reports on two new studies. 

The first study found
that the genetic structure of gut microbiome was more predictive of health than
one’s own genes.  It was especially better for “complex”
diseases that are attributed to both environmental and genetic factors. 
Gut microbes are impacted sooner by environmental factors and thus serve as
better predictors for such diseases. 

The second study found
that a person’s microbiome could be used to predict their death 15 years
later.  Presence of a certain family of bacteria led to a 15% higher
mortality rate in the next 15 years.  Whether the bacteria are the cause
of the mortality or a side effect of other factors is not clear. 

Credit: Finlay, et al. Science Magazine.

The second article was a study from B.B. Finlay, et. alia, that speculated that
so-called non-communicable diseases (NCD) might actually be communicable, via
the microbiome.  I.e., “we propose that some NCDs could have a microbial
component and, if so, might be communicable via the microbiota.”

The authors looked at
obesity, Type 2 diabetes, cardiovascular disease, and inflammatory bowel
disease as possible examples.  “These observations suggest that the
microbiota could be a causal and transmissible element in certain diseases that
have been traditionally classified as NCDs,” the authors conclude, further
noting: “Additionally, only gut bacteria have been considered in this
discussion, yet viruses and fungi may also contribute to NCDs, as well as
microbiota at other body sites such as the skin and oral cavity.”

Their paper
concludes: 

These findings could serve as a solid framework
for microbiome profiling in clinical risk prediction, paving the way towards
clinical applications of human microbiome sequencing aimed at prediction,
prevention, and treatment of disease.

Dr. Finlay says: “If our hypothesis is proven correct, it will rewrite the
entire book on public health.”

Microbiome researcher
Samuel Minot, PhD, who was not involved in the studies, is told Mr. Ortega, “I am hopeful and enthusiastic that the community will
reach a point where we’re able to develop microbiome-based therapeutics and
diagnostics.  I think that this is within the realm of
possibility.”  

Professor Harry Sokol of the Paris Center for Microbiome Medicine
agreed, telling Gut Microbiota for Health: “I
am convinced that some microbiome-based tests will become biomarkers in many
clinical situations in the future.”  

There is much work going
on in the field.  For example, The
Cleveland Clinic has the Center for Microbiome and Human Health, the
Mayo Clinic has the Microbiome Program, Stanford has the Stanford Microbiome Therapies Initiative, UCSF has the Benoff Center for
Microbiome Medicine
, the University of Pittsburgh has the Center for
Medicine and the Microbiome
, and the University of
Wisconsin has the Center for Microbiome Sciences & Therapeutics.

Still, it is too early
to get overly excited.   Everyone agrees more research is necessary. 
Timothy Caulfield, the Research Director of the Health Law Institute at the
University of Alberta, warns: “Gut hype is everywhere.”  He acknowledges that
this is an exciting field with great promise, but cautions “it is still
early days for microbiome research.”  

Think of modern
medicine, with its germ theory of disease and its understanding of our body’s
biomechanics, as classical physics.  See a germ, kill a germ. 
Monitor our bodily functions, test our blood, even sequence our genes; all the
answers lie within us.  Newton would approve.

Our recent discoveries
about our microbiota are upending our notions about what disease is, what
causes it, and how we should best deal with it.  Our supposed precision in
medicine is illusionary. Heisenberg would understand.  

Credit: Kateryna Kon/Science Photo Library, via Getty Images

Modern medicine loves
its antibiotics, despite the devastating impact they wreak on our
microbiome.  It is fascinated with our genome, despite the fact that our
microbiota’s genes greatly outweigh our own, and have more diversity.  Our microbiota
change in ways that we don’t understand and, as yet, can’t even really track,
much less predict the effect of.   

We need the equivalent
of a quantum theory of health.  

I don’t mean literally
applying quantum physics to healthcare, although, of course, we are a
collection of quantum bits.  I mean recognizing that our human-centric
picture of health is much too narrow, and fails to predict what actually drives
our health.  I mean admitting that “our” health is really a
consequence of “their” health, and that only figuring out how to
incorporate both will yield us a true picture of health.   

Modern medicine is in
the stage physics was in the early part of the 20th century, when the concept
of quanta was known but the consequences of it were yet to be discovered. 
Physics struggled for many years to accept quantum theory, and medicine will
have a similar struggle to accept whatever the theory that fully incorporates
microbiota will be.  

Modern medicine has had its
Newtons, maybe even its Einsteins, but now it needs a new generation of
scientists to develop more accurate theories of our health, no matter how
counter-intuitive they might be.  

Welcome to a quantum theory of health.

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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Consumer Weight Loss Platform Noom Heads for Digital Health | Saeju Jeong, CEO, Noom

BY JESSICA DAMASSA

Popular weight management app Noom is officially stepping into the world of digital health and digital therapeutics. CEO & co-founder, Saeju Jeong, shares some of the impressive stats that the behavior change platform has been able to help users achieve — including an average 7.5% reduction in body weight in 6 months. With more than 1 million (!) users around the world already, Noom is expanding globally and is venturing further into the healthcare space as a result of their successful pilot with Novo-Nordisk, which saw Noom as a ‘wrap around’ support to the drug company’s diabetes medication. On tap next, Saeju tells us he’s headed further into diabetes management, hypertension, kidney failure, and various cardiac conditions.

Filmed at Frontiers Health in Berlin, Germany, November 2019.

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Strategic Interests and the ONC Annual Meeting

By ADRIAN GROPPER, MD

The HHS Office of National Coordinator (ONC) hosted a well-attended Annual Meeting this week. It’s a critical time for HHS because regulations authorized under the almost unanimous bi-partisan 21stC Cures Act, three and a half years in the making, are now facing intense political pressure for further delay or outright nullification. HHS pulled out all of the stops to promote their as yet unseen work product.

Myself and other patient advocates benefited from the all-out push by ONC. We were given prominent spots on the plenary panels, for which we are grateful to ONC. This post summarizes my impressions on three topics discussed both on-stage and off:

  • Patient Matching and Unique Patient Identifiers (UPI)
  • Reaction to Judy Faulkner’s Threats
  • Consumer App Access and Safety

Each of these represents a different aspect of the strategic interests at work to sideline patient-centered practices that might threaten the current $Trillion of waste. 

The patient ID plenary panel opened the meeting. It was a well designed opportunity for experts to present their perspectives on a seemingly endless debate. Here’s a brief report. My comments were a privacy perspective on patient matching, UPI, and the potential role of self-sovereign identity (SSI) as a new UPI technology. The questions and Twitter about my comments after the panel showed specific interest in:

  • The similarity of “enhanced” surveillance for patient matching to the Chinese social credit scoring system.
  • The suggestion that we already have very useful UPIs in the form of email address and mobile phone numbers that could have been adopted in the marketplace, but are not, for what I euphemistically called “strategic interests”.
  • The promise of SSI as better and more privacy preserving UPIs that might still be ignored by the same strategic interests.
  • The observation that a consent-based health information exchange does not need either patient matching or UPIs.

It seems inconceivable to me that the TEFCA national health information network can be built on coercive surveillance instead of some combination of consent and UPIs. HHS controls TEFCA and they will have to deal with this in 2020.

Second, there was fierce reaction from patient advocates, activist patients, and academics to Judy Faulkner’s threat to sue HHS if the final regulations look like the most decent drafts. All three of these perspectives are very much worth reading. All three ask ONC to push for the strongest information blocking rules without delay and I agree.

However, the reaction from the academics, the proud architects of SMART on FHIR, doesn’t acknowledge the pact they made with Epic years ago. Neither the big academic hospitals that drove SMART nor the big hospital EHR vendors like Epic were interested in designing a patient-centered system. SMART on FHIR is conceived as apps that must run in the EHR and under the control of the hospital. SMART is a hospital-centered design, not a patient-centered design. This reflects the shared strategic interest of the EHR vendors and their big hospital customers. My pleas to the SMART and HL7 designers to enable patient-directed access were and still are quietly ignored.

The third topic of interest from a patient-centered perspective was evident in the plenary panel about consumer apps and the privacy risks from their lack of HIPAA protection. The strategic interests were in full display, all asking for convenient access to health records on behalf of patients. One panelist described their success in pulling up a patient record on their smartphone and handing it to a doctor that would otherwise have had no way to see them. The commercial interests were eager for the new regulations to create a market for their solutions.

The problem with these consumer apps is that very few doctors can or will access them in the normal course of events. The apps all present different and unfamiliar interfaces, are not accessible unless the patient is in the room, and cannot easily transfer information into whatever EHR the clinician is using. One of the leading proponents of this patient access ghetto strategy is the CARIN Alliance lobby. It goes as far as to declare that their best practices will not support patient-to-provider communications.

What was entirely missing from the consumer access panel and, as far as I can tell, from the entire ONC Annual Meeting agenda, is any discussion of a longitudinal health record, a patient-centered health record that hospitals, physicians, as well as family caregivers could all access and update to ensure that everyone was on the same page. A cynic might ask: where’s the money or strategic interest for that?

Adrian Gropper, MD, is the CTO of Patient Privacy Rights, a national organization representing 10.3 million patients and among the foremost open data advocates in the country. This post originally appeared on Bill of Health here.

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Disrupting How We Detect Asthma & Hypertension | Edward Allegra, BioLum Sciences

BY JESSICA DAMASSA

BioLum Sciences is introducing new chemistry that has the potential to completely change the way we test for respiratory illnesses, like asthma, and analyze blood samples to identify hypertension. CEO Edward Allegra talks through the science behind both their breath and blood tests, both of which are patent-pending and have the ability to completely bend the cost-curve when it comes to identifying and monitoring these two common chronic conditions. What’s next for the early-stage health startup? A range of applications to detect everything from COPD to lung cancer and more.

Filmed at Bayer G4A Signing Day in Berlin, Germany, October 2019.

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