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New Models of Healthcare Delivery and Retailers Producing Big Data

Susan C. Hull

INTRODUCTION

Informatics nurses bring over half a century of legacy to the global impact the effective use of health information technology (Health IT) has had on advancing the safety, quality, and efficiency of healthcare services to improve the health of individuals, communities and nations. The confluence of regulatory, business, and social changes with the activity of formidable industry digital disrupters are reframing relationships, care, and payment models across the healthcare ecosystem. While some of these efforts include informatics nurses in leadership roles, many have not fully tapped into the profound contribution nurses must make in designing, leading, staffing, and supporting these emerging models. Informatics nurses are needed to bridge the knowledge gap to nurses in practice, education, research and policy, across all settings.

Amazon, Apple, Google parent company Alphabet, and Microsoft, considered the “big four” disruptive technology companies, have been building momentum in healthcare for well over a decade. The confluence of their consumercentric focus, ability to understand the needs of individuals, massive AI/big data science capabilities, flurry of recent health partnerships, and advances in digital health innovation set context for these evolving new healthcare models. These digital disrupters bring market value directly related to the value of how data elements can be linked, classified, combined, and reorganized to create more value, and how innovative models, algorithms, and methods of analysis support emerging healthcare models (Press, 2018). Big data production supports rapidly emerging new value-based care models. See Confluence of Capabilities: Digital Health Disrupters, in Table 36.1

Healthcare retailers like CVS Health, Amazon, and Walmart are leading the movement to open their digital front door to healthcare. CVS Pharmacy, RiteAid, Target, Walgreens, and Walmart are making bold moves with a variety of healthcare payer, provider, and technology partners to offer direct-to-consumer care through telehealth platforms and mobile health apps, and direct-to-consumer video visits for non-life-threatening health concerns. These services complement their in-retail clinic and online health offerings and encourage convenience and avoidance of the timeconsuming and expensive visits to the hospital emergency department or doctor’s office (Wicklund, 2018a).

Healthcare payers, both traditional and new entrants, are also experimenting with disruptive value-based care delivery models, by partnering and/or merging with these retailers and provider health systems to offer virtual and concierge services to large provider networks. Digital Health vendors are blurring the lines and becoming virtual primary, specialty, chronic, urgent and house-call care providers by establishing relationships with payers, providers, retailers, large employers, and consumers themselves. A diverse set of new partnerships are rapidly emerging, each bringing novel solutions to a rapidly changing ecosystem.

This chapter describes examples of these digital disrupters and emerging healthcare models with a focus on implications for engaging informatics nurses in the design, socialization, implementation, and evaluation of these models. In some cases, nursing roles and scope of practice are well defined and demonstrated outcomes are further driving the spread and scale of these models. In most cases, the early approach and outcomes are speculative, and nursing roles beyond advanced nurse practitioners, are not clearly defined.

Given its scope, this chapter recognizes yet excludes the U. S. Centers for Medicare & Medicaid (CMS) Innovation Center–funded projects and initiatives for care delivery and payment model innovation from consideration. These efforts continue to design and test innovation models and seek engagement of nurses and informatics nurses. The growing portfolio of projects that aim to achieve better care for patients, better health for our communities, and lower costs through improvement for our healthcare system are profoundly disruptive and will mash-up in novel ways with the new models described in this chapter.

DRIVERS FOR NEW CARE DELIVERY MODELS

The primary driver for emerging value-based care models is the broad recognition that our health system is fundamentally broken, costs are unaffordable and unsustainable, and the system itself needs a serious repair. The continued escalation of the cost of care and the push for price and value transparency are adding substantial pressure to the urgency for change. It is difficult for any one stakeholder— individuals and families, business and employers, health care system providers, public and private payers, pharmaceutical and life science companies to grasp the magnitude of the cost of care and their contribution to it.

Most Americans for example do not understand they are bearing the primary cost of healthcare because they are not directly paying for it. Despite efforts to reduce the total cost of care over the last three to four decades by coalitions of communities, businesses, and employers, it costs companies and their workers close to $20,000 to insure a family, up 55% in the last decade—before even seeing a healthcare practitioner. U.S. healthcare spending increased 3.9% to reach $3.5 trillion, or $10,739 per person in 2017. The private funding for healthcare accounted for 34% spending, Medicare 20%, Medicaid coming out of state budgets at 11%, out of pocket from consumers 10%, other private spending 7%, and other government such as military at 12% (Centers for Medicare and Medicaid Services (CMS), 2017).

Communities, while long recognizing their role in transforming the health of individuals and communities are recognizing the disruptive power they can mobilize through collaboration and big data production to support the understanding and reduction of the total cost of care in their community (Mitchell, 2017; Hull & Edmunds, 2019).

The Network for Regional Health Improvement’s (NRHI’s) Getting to Affordability Initiative: Regional Total Cost of Care project (funded by the Robert Wood Johnson Foundation) is an exemplar effort empowering the community to measure and impact the total cost of care (TCoC) within and across regions and the differences across communities (NRHI, 2019). With five pilot regions and thirteen expansion regions, these communities are tackling cost head-on by producing standardized, high-quality data analysis of the local cost of care, sharing information and collaborating to produce local change. NHRI’s related Affordable Care Together Movement is focused on disruptive care models by addressing three major drivers: health, price, and waste.

One of the most tangible drivers catalyzing care model disruption is the almost decade momentum for consumers to have access to their digital health data (Markle Foundation, 2008; Ricciardi, Mostashari, Murphy, Daniel, & Simerino, 2013; Hull, 2014; Daniels, Deering, & Murray, 2014). Recent proposed rulemaking issued by CMS focuses on moving the healthcare system in the direction of interoperability and improve patient access to health data. It further signals CMS’s continued commitment to the vision set out in the 21st Century Cures Act and Executive Order 13813: to improve access to, and the quality of, information that Americans need to make informed healthcare decisions, including data about healthcare prices and outcomes, while minimizing reporting burdens on affected plans, healthcare providers, or payers (Centers for Medicare & Medicaid Services (CMS), 2020).

Nonpartisan cross-sector industry alliances and collaboratives, healthcare advocacy and standard development organizations, are also supporting consumer’s access to and aggregation of health information, promoting technical solutions to facilitate ease and transparency in its exchange. The Alliance for Nursing Informatics (ANI) is supporting informatics nurses to be engaged in advocacy for consumer health at the board policy level, including roles in The CARIN Alliance and Exertia (Tiase & Hull, 2018; Dunn Lopez &Tiase 2020). Through collaboration with risk-bearing providers, payers, consumers, pharmaceutical companies, consumer platform companies, health IT companies, and consumer-advocates, CARIN Alliance members are working collaboratively with other stakeholders in government to overcome barriers in advancing consumer-directed exchange across the United States. Efforts include advancing a Common Payer Consumer Data Set (CPCDS) and increasing transparency of health data access and aggregation across clinical and claims data for citizens (CARIN & CPCDS, 2019).

DISRUPTIVE CARE DELIVERY MODELS

Diverse industry partnerships, pilots, and market-moving activities are shaping major disruptions in how care is delivered and paid for. Disruptive technologies including cloud-based open collaboration and development platforms, artificial intelligence and advanced analytics, genomics and precision health, virtual care modalities, and population health tools are fostering experimentation, innovation, and pilots moving to scale. The big four disruptive technology companies are bringing new care delivery solutions and new tools for research and development. Of interest, few of these disruptive care models have defined roles for nurses explicitly, beyond care management and advanced nurse practice provider roles. Coverage of nursing roles across the models and examples is uneven, with many opportunities to advance nurse-led care models. Nurse informatics have many opportunities to partner, evaluate, and innovate in leading and supporting roles.

While the use cases described here may individually signal a specific new care model, the synergy across these examples for integrating these disruptive technologies to bridge care and collaboration for consumers and clinical providers is not to be understated. The disruptive technologies cross and blur traditional care and payment boundaries and geographies, with technology bringing together patients, consumers, and clinicians together in novel ways for both consumer-directed and clinically directed health care and research activities. These models are changing rapidly, with a tremendous focus on direct-to-consumer options. Selected examples are organized within these categories:

•   Healthcare Initiatives of the “big four” disruptive technology companies

•   New payer models

•   New payer-provider models

•   New retail partnerships or acquisitions

•   Digital health startups becoming providers

Healthcare Initiatives of the “Big Four” Disruptive Technology Companies

Apple Apple has accelerated momentum in healthcare innovation with the ubiquitous spread of the iPhone (launched in 2007), iPad (launched in 2010). Related capabilities with the release HealthKit and Healthkit API in 2014; Apple Watch in 2015; ResearchKit in 2015 and ResearchKit API in 2018; CareKit in 2016, CareKit API in 2017; and Health Records API in 2018 have catalyzed a flurry of diverse use cases and research studies across hospitals, clinics, physicians, labs, retail, life sciences companies, and with consumers themselves (9to5Mac, 2018; Elmer-DeWitt, 2019). Apple promotes IOS products and apps to improve care and efficiency for clinicians, nurses, and patients for care in the hospital, chronic care in the community and at home, while also promoting these tools to life sciences and pharmaceutical industries.

Throughout 2017–2019, the confluence of Apple announcements signals the intensity of their healthcare interests and capabilities across use cases, products, partnerships, and geographies (Comstock, 2017b; Mack, 2017a; Elmer-Dewitt, 2019). Dates are included for relative momentum of efforts. Examples include, but are not limited to Apple’s:

•   Partnership with UK-based Physitrack and mobileenabled electronic health record (EHR) developer DrChrono (February 2017) to integrate a home exercise program into the EHRs Web, iPad, iPhone, and Apple Watch (Mack, 2017b).

•   Acquisition of sleep tracking hardware and software Finland-based company Beddit (May 2017), which works with apps for IOS and Apple Watch, signaling a deeper interest beyond the inclusion of their sleep monitor products in Apple stores since late 2015. Apple released their first Beddit 3.5 Sleep Monitor (December 2018), a 2-mm thin sensor strip placed under a bedsheet to track body movements, measure sleep time, heart rate, breathing, snoring, and bedroom temperature and humidity. The sensor can connect to the Apple watch and to Beddit’s third-party app for sleep analysis and heart rate tracking (Lee, 2018).

•   CareKit enhancements (2016), while originally designed for consumers, that make it easier to connect apps to hospital back-ends, and provides a new view for patients that combines the information in the Care Card and Symptom Tracker views, for easier care plan progress assessment. The CareKit Blog describes progressive enhancements over time (CareKit Blog, 2016).

•   ResearchKit 2.0 enhancements that include audiovisual and user interface improvements for developers and study participants, making it easier to add instructional videos. Improvements in attention measuring capabilities such as the Stroop test for mental processing and Trail Making Test to assess for visual attention and task swapping offer support for the proliferation of neurocognitive assessment apps (2017).

•   HealthKit enhancements that focus on Apple’s deeper interest in closed-loop diabetes interventions. These include tracking blood glucose, relative mealtime to the sample (preprandial and postprandial glucose as different fields), insulin delivery dose for basil and bonus, carbohydrates and diverse activity data. In addition, Apple announced that Dexcom would take advantage of the Apple Watch’s native Bluetooth to allow Dexcom’s Continuous Glucose Monitoring (CGM) users to access their blood glucose data directly from the Watch, even if they’ve left their phone at home (Comstock, 2017a).

•   Launch of the Apple Heart Study, a virtual health study funded by Apple, focused on Atrial Fibrillation with Stanford, American Well (for telemedicine consultations), and bio-telemetry (EKG patches) (November 2017). By March 2019, preliminary results revealed that this study enrolled an unprecedented 400,000 patients, and that wearable technology can safely identify heart rate irregularities, which subsequent testing confirmed to be atrial fibrillation (Stanford Medicine News, 2019).

•   Launch of Zimmer Biomet mymobility™ health app in October 2018, and a two-year clinical study designed to measure patient outcomes and overall cost, for hip and knee replacement surgery. The study will track patient-reported feedback with continuous health and activity data from the Apple Watch in up to 10,000 patients. Seven hospitals and academic medical centers and eleven group practices and ambulatory surgical centers are participating (Zimmer Biomet, 2018).

•   Launch of Health Records in IOS 11.3 (January 2018) with FHIR-based standard API, allowing consumers to (1) access and aggregate their health records to their iPhone or iPad, and (2) leverage OAuth 2.0 that allow users to authenticate once and create an enduring connection with the consumer’s EHR API to pull in any new health records and notify the user when new records are available. The effort started with 12 partnering health systems and the Department of Veteran’s Affairs, the support of the Carin Alliance, three EHR vendors (Athena Health, Cerner, and Epic), Lab Corp and Lab Quest data, and has expanded to near 300 organizations/practices (as of June 2019). A recent announcement expands the offering further by allowing U.S. clinics and healthcare organizations with compatible EHRs to self-register for the personal health record system (Muoio, 2019a).

•   Expansion of the Apple Watch Series 4’s ECG functionality, now in its fourth generation, to Hong Kong and 19 European countries including France, Germany, Italy, Spain, and the United Kingdom (March 2019). With De Novo clearance received in the United States from the FDA, the ECG app and irregular rhythm notification are now CE marked and cleared in the European Economic Area (Apple Newsroom, 2019).

•   Offer of OneDrop’s wireless glucose monitoring system combined with a year of unlimited access to certified diabetes coaches, available in select US Apple stores (June 2019). The mobile app supports Apple’s HealthKit, CareKit, Health Records, and Siri Shortcuts on the iPhone, and the glucose monitor. The One Drop mobile app also forecasts user’s eight-hour project of glucose levels built on its machine learning-based predictions powered by over 2.2 billion data points, collected from more than 1.2 million users. Alongside each forecast, users also receive advice on relevant behaviors for maintaining time-in-range (One Drop, 2019).

•   As part of multipronged effort to mitigate the spread of COVID-19, Apple announced April 2020 their global effort to support local governments and public health authorities by providing mobility data trends generated from Apple Maps. The reports show the change in volume of people driving, walking or taking public transit in their communities, as a proxy for understanding compliance with local “shelter in place” health orders. Additionally, Apple and Google announced a partnership to enable the use of Bluetooth technology to help governments and health agencies reduce the spread of the virus through citizen engaged contact tracing. (Apple Newsroom, 2020).

Amazon In January of 2018, when CEOs Warren Buffet (Berkshire Hathaway), Jamie Dimon (J.P. Morgan Chase and Co), and Jeff Bezos (Amazon) got together to formulate a plan to address the rising cost of healthcare, for their 1.2 million employees, a frenzy of market interest and speculation ensued. These conversations created a ripple effect, with all parts of the healthcare ecosystem scrutinizing and speculating about the pace and reality of new healthcare catalyzed by these digital disrupters, the first CEO who has subsequently moved on in May 2020. In June 2018, the new nonprofit company, “focused on changing the way people experience health care so that it is simpler, better, and lower cost” and attracted Atul Gawande MD as CEO. The company has been recently named Haven in March 2019 (LaVito, Farr, & Son, 2019).

Haven’s new Web site reveals additional focus, including improving the process of navigating the complex healthcare system and accessing affordable treatments and prescription drugs. Senior executive team members being recruited from diverse sectors, including nationally prominent healthcare providers, prayers, and start-ups. Clinical staff appears to be in recruitment, but few details frame unique roles for the nurse or nurse informatics beyond the generic “clinical” role, with limited information, and instructions to “apply here.” Industry speculation predicts that Haven will develop its own clinically integrated network for the employer to directly contract with by first building a curated network of doctors by analyzing performance, cost, and other data and steer members to the lowest cost provider and level of care (American Hospital Association, 2019).

Amazon acquired PillPack, a virtual pharmacy company (September 2018), for an estimated $1billion, and began the initiation of a direct-to-the consumer marketing campaign to Amazon Prime customers (April 2019). Licensed to ship prescriptions to all states except Hawaii, it can fill schedule III, IV, and V medications, delivering individualized packages of presorted medicines. It is unknown how many of the estimated 85–100 million Amazon Prime members is it targeting (Pfifer, 2019). PillPack competes with Walmart and with major pharmacies including CVS Health (owned by Aetna); health plans who own pharmacy benefit managers including Express Scripts (owned by Cigna); OptumRx and UnitedHealth Group; and Anthem’s IngenioRx. Express Scripts, CVS Health, and OptumRx control pharmacy benefits for about 75 to 80% of the U.S. population.

Amazon announced (April 2019) that its voice-based Alexa platform now supports the development of software that communicates HIPAA-protected health information through an invite-only Alexa Skills Kit program. Six pilots are being conducted (Jiang, 2019):

1.   Pharmacy benefits manager members can query Alexa to check the status of home delivery prescriptions including receiving voice notifications of shipment (Express Scripts).

2.   Health plan employees can manage personal health improvement goals and wellness incentives (Cigna).

3.   Parents and caregivers enrolled in an Enhanced Recovery After Surgery Program can provide postoperative care team updates and recovery progress through Alexa and be updated on postoperative appointments (Boston Children’s Hospital).

4.   Patients across a 51-hospital health system across seven states can query Alexa to find an urgent care center near them and schedule a same day appointment (Providence St. Josephs).

5.   Customers in North and South Carolina can find an urgent care location within the 40 hospitals and 900 care location (Atrium Health).

6.   Members of a digital health company for chronic conditions can query Alexa for their last blood glucose reading, measurement trends, and receive insights and health nudges personalized to the individual (Livongo).

Google and Alphabet Google has been engaged in healthcare well over a decade, including the start and then the failure of the personal health record, Google Health (2008–2011); Google Flu Trends (2009); the acquisition of London-based artificial intelligence firm, Deep Mind, and the release of Google Fit (2014). Alphabet, a multinational conglomerate established in 2015, is Google’s parent company. Like the other big four, Google’s health initiatives have intensified over the last 4 years. Examples include, but are not limited to Google and Alphabet’s:

•   Calico, bringing scientists from the fields of medicine, drug development, molecular biology, genetics, and computational biology. It is focused on research to understand how biology controls the lifespan, including antiaging research. Formed as a research and development company by Google (2013), Calico has announced partnerships with:

   The Broad Institute of MIT and Harvard focusing on the biology and genetics of aging and early-stage drug discovery (2015);

   UCSF Walter Laboratory to license technology focused on modulators of the Integrated Stress Response (ISR), a set of processes activated in cells under conditions of stress (2015);

   The Buck Institute, to research the biology of aging and to identify potential therapeutics for age-related diseases (2015);

   Ancestry DNA, to investigate human heredity of lifespan (2015);

   C4Therapuetics, a five-year collaboration to discover, develop, and commercialize therapies for treating diseases of aging, including cancer, by focusing on small molecule protein degraders as therapeutic agents to remove specific diseasecausing proteins (2017).

•   Acquisition of London-based artificial intelligence company DeepMind (2014), followed by a variety of efforts, including the announcement that the team behind Streams will be joining Google (November 2018). Streams is an AI-powered assistant and mobile app for nurses and physicians to support rapid response teams, early detection of sepsis, and acute kidney injury (Postelnicu, 2018).

•   Verily Life Sciences (formerly Google Life Sciences). It was created in 2015 to focus on harnessing health data, through the use of artificial intelligence, for clues that might predict and prevent diseases through partnerships with healthcare companies and universities (Harris, 2019). Verily is most known for an early project to develop smart contact lenses that can measure glucose levels for people with diabetes. In November 2018, the project was stalled with the recognition that the effort was not able to obtain accurate glucose readings from tears. Other Verily initiatives include, but are not limited to:

   Partnership with Duke University and Stanford University to launch Project Baseline (2017) to bridge the gap between research and care and create a more comprehensive map of human health. The 4-year observational populational health study hopes to recruit 10,000 volunteers to share data to the company, as well as add other partnering sites.

   Joint venture with ResMed (July 2018) to study the health and financial impacts of undiagnosed and untreated sleep apnea, and develop software solutions that enable healthcare providers to more efficiently identify, diagnose, treat, and manage individuals with sleep apnea and other breathing-related sleep disorders (Lovett, 2018).

   Partnership with the American Heart Association to expand the Project Baseline Health Study, to include the Baseline Platform, an end-to-end evidence generation platform for patients and clinicians.

   Partnership with the American Heart Association to initiate Research Goes Red that is both a movement and a research study, to engage women in heart disease research (February 2019).

   Direct-to-the-consumer Project Baseline studies, including: (1) heart biomarker study to understand an emerging risk factor Lipoprotein(a) or Lp(a); (2) a series of 1–2 hour in-person sessions or 5-minute surveys to engage consumers in research codesign; (3) a one-year, Type 2 Diabetes study with the goal of engaging 200 citizens to collaborate with Verily to test a smartphone app and health coaching program and use both medical and nonmedical devices; and (4) a 12-week, smartphone-based Mood Study.

   Creation of a new nonprofit health ecosystem OneFifteen with two health networks, Kettering Health Network and Premier Health to combat opioid addiction. Efforts include building a high-tech rehab campus in Dayton, Ohio, and Verily’s integration support to operate as a learning health system. Verily will support the application of analytics to measure the effectiveness of various interventions, with a focus on stringent standards for patient privacy and data security. Clinical care will be serviced by an operating partner of OneFifteen, Samaritan Behavioral Health, Inc., a subsidiary of Premier Health. The new campus opened for patients in June 2019. A Registered Nurse is the President and Chief Executive Officer and will oversee OneFifteen Health and OneFifteen Recovery (Precision Newswire, 2019; P&T Community, 2019).

   Strategic alliances with Novartis, Otsuka, Pfizer, and Sanofi (May 2019) to develop new clinical research programs utilizing the Project Baseline platform across therapeutic areas ranging from cardiovascular disease to oncology to mental health (Truong, 2019).

   New Project Baseline Health Consortium (May 2019) formed to bridge the gap between research and care, with inaugural members: Verily, Duke University Health System, Vanderbilt University Medical Center, University of Mississippi Medical Center, Mayo Clinic, Regional Health in South Dakota, and University of Pittsburgh.

   Joint venture Onduo by Verily and Sanofi as a virtual care program (launched February 2018), featuring a Virtual Diabetes Clinic, diabetes tools, coaching, and clinical support. Staffed with a team of expert Certified Diabetes Educators, doctors, nurses, nutritionists, pharmacists, data scientists, programmers, and engineers, the program is targeted to payers, employers, and primary care physicians. It does not appear that a nurse is in a leadership or advisory board role. Sutter Health of Northern California and Allegheny Health Network of western Pennsylvania are among the first healthcare networks to collaborate to test the Onduo platform. Partnerships are expanding, including with a diabetic foot ulcer sensor company Orpyx Medical Technologies (June 2019), with a vision of a world where everyone has access to the medical care and resources they need, no matter where they live or what health conditions they face.

   Dr. David Feinberg MD, a child psychiatrist and health executive from UCLA and Geisinger, was appointed Head of Google Health in January 2019 (Google, 2019). To follow, October 2019, Dr. Karen DeSalvo M.D., M.P.H., M.Sc., is named Google’s first Chief Health Officer (CNBC, 2019).

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