Category: Life Sciences Industry

How Decentralized Clinical Trials Put the Patient Experience at the Forefront | Blog

How Decentralized Clinical Trials Put the Patient Experience at the Forefront

With the COVID-19 pandemic accelerating the adoption of Decentralized Clinical Trials (DCT), the opportunity to deliver a patient-centric experience is viewed as a top benefit of this alternative mode of clinical trials that uses digital and remote technologies. What factors are enterprise buyers looking for DCT vendors to provide in their platforms to increase satisfaction and ultimately drive patient enrollments? Learn about the five factors that go into a “patient centered” experience in this blog.

When COVID-19 brought traditional clinical trials to an abrupt halt, Decentralized Clinical Trials (DCT) proved to be a savior for sponsors looking to safely restart their paused research activities. While DCTs have been around for a decade and are slowly gaining traction, the pandemic accelerated the use of these alternative methods to collect clinical trial data through sensors or remote monitoring devices carried by a patient.

The top reason for moving toward this model has been its patient-centered focus that makes it easier for more people from a broader geographic area to participate in trials without the need to visit a site.

The growing mainstream acceptance for DCTs has increased the appetite among clinical research organizations (CROs) and sponsors to adopt the latest technologies and virtual models for clinical trials. This has resulted in an uptick in innovation and DCT product adoption recently. We see DCT vendors increasingly focus on co-innovation, continuous product improvement, and market education to help clients get started on their DCT journey.

Top benefits of DCT adoption

Our Decentralized Clinical Trial Products PEAK Matrix® Assessment 2021 found the most promising benefit for enterprises to consider decentralizing their trials is the opportunity to enhance the patient experience – a benefit that two out of three DCT product buyers also agree with based on Everest Group interviews. Other advantages of DCTs include reducing trial costs and timelines, attracting a more diverse patient population, and capturing real-time data for trials.

With DCTs, patients can now take part in a study from the comfort of their homes, spend more time with their family members, and focus on work and other responsibilities. This mode of clinical trial also opens the door to the patients who suffer from mobility issues and allows sponsors to reach a global audience, increasing inclusivity and diversion.

This new patient-centric approach is driving increased enrollment and retention rates. With these valuable benefits, it is not surprising that having a people-orientated platform has become central to enterprise buyers in making their sourcing decisions – even more so than innovation or reviews from other buyers.

What do buyers want from DCT vendors?

What do enterprises buyers mean when they talk about patient experience? Multiple facets contribute to the notion of patient experience as presented in the exhibit below.

Exhibit 1: What enterprises buyers mean when they say patient experience

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Five factors to enhance patient experience with DCTs

Patient experience can be broken down into the following aspects:

  • User-friendly interface – The User Interface (UI) of DCT applications and devices must be simple, yet effective. They must provide clear instructions and display only relevant and concise content. It should be well organized, making all options easily accessible and ensuring that the application can be used with minimal explanation
  • Easy to set up platform/app – Patients should have an easy time setting up a wearable, sensor, or application. It should be intuitive even to an average user with limited exposure to digital devices. The device should be as close as possible to a ready-to-use mode
  • Smooth operation – The applications or devices should not pester patients with unnecessary notifications, malfunctions, or failures that would cause unwanted frustrations, resulting in reduced patient engagement. A smooth operation with minimal or zero disruption is the best-case scenario
  • Robust education and training – Patients come with different levels of digital literacy, and they need to be supported during the trials. They must be aware of how to enroll themselves for the trial, schedule appointments, feed in data, and get important information about their health and the trial. Sponsors can create the knowledge pool, conduct training sessions, and build artificial intelligence (AI) bots to provide education and training to patients
  • Multilingual app and support – To reach a global audience, multilingual offering and support must be available. The devices or applications used should provide instructions and information in the commonly used languages across the world. If a trial is geographically focused, the regional language should be configured in the device

Enterprises want DCT solutions to integrate smoothly into the daily lives and operations of patients. Patients should not feel isolated when doing the trial since the significant amount of digital literacy required might deter them from participating.

Vendors also need to be aware of the top patient-related challenges that might hinder them from elevating the patient experience through their products and services. Multiple challenges might lead to an inferior experience, resulting in disengagement and dropouts. DCT vendors and enterprise buyers must identify these challenges and take discrete steps to improve the patient experience and engagement.

Keep following this space as we dive into the top patient-related challenges and present initiatives aimed at improving the patient experience.

What are your views on the patient experience in DCTs? Reach out to [email protected] and [email protected] to discuss more.

How Analytics and Automation Can Help Health Plans Improve Medicare Advantage Star Ratings | Blog

Customer analytics and automation solutions can be a key differentiator in helping health insurers achieve better Medicare Advantage (MA) Star Ratings with changes that emphasize the customer experience coming by 2023. At a time when delivery of high-quality healthcare services is a priority and competition is intensifying, taking the right steps now can make a difference for both providers and patients. To learn more, read on.     

Why the MA Star Ratings are important

Health care quality and MA enrollments have significantly improved since the Centers for Medicare & Medicaid Services (CMS) introduced a five-star rating system in 2007 that scores each plan’s performance across numerous measures over a prior 18-month period.

The major goals of the MA Star Rating program are to incentivize insurers to improve their performance and to help patients compare and choose high-quality plans. These Star Ratings have become a crucial yardstick to help beneficiaries select the best plan for themselves.

As a result of the program, more customers are enrolled in higher-quality health plans. According to Medicare, MA enrollment has more than doubled in the past decade, with 26 million Americans currently enrolled this year.

What led CMS to change the ratings?

Over the years, the criteria used to assess plan performance has become more stringent, with CMS changing the cut-point levels to achieve the ratings across 47 different measures. Even after raising the standards, average scores have improved, reflecting a continued push by providers to improve the quality of services.

The Star Rating divides the measures into separate categories and assigns a different weight to each area. In May 2020, CMS increased the weight given to measures related to customer experience, such as patient experience, complaints, and barriers to receiving care, from 35 percent of the total score last year to comprising nearly 60 percent of the overall rating by 2023.

CMS made this change to encourage plans to provide the best service to beneficiaries, resulting in better engagement and health outcomes.

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Patients’ Experience and Complaints Measure: These reflect beneficiaries’ perspectives of the care they received

Measures Capturing Access: These reflect processes and issues that could create barriers to receiving needed care

How does this impact health plans?

The changes in the Star Ratings can bring significant value to plans in the following ways:

  • Increased revenue – Better Star Ratings can lead to an increase in member enrollment, resulting in higher revenue
  • Financial incentives – CMS offers financial incentives in the form of bonus payments known as Quality Bonus Payments (QBPs) to plans that achieve high star ratings. In addition, the share of savings that plans must provide to enrollees as the beneficiary rebate is tied to the plan’s rating. Plans that are awarded four or more stars earn a five percent bonus payment. They also receive higher rebates that are returned to the members in the form of supplemental benefits or lower premiums
  • Improved customer engagement – By improving their ratings, plans also benefit from higher plan renewals and lower attritions while driving down operational costs

Insurers will have to strategize differently to understand how the rating changes affect them. For example, a plan that currently has the highest 5-star overall rating but average scores in customer metrics will see a decline in its overall ratings if it maintains similar scores in 2023 because of the increased weight given to customer-related metrics.

For plans that have ratings below 5-star, this change represents a big opportunity to significantly increase their overall ratings by improving their customer metrics.

What’s next?

Currently, nearly all plans use customer analytics and automation in some capacity to drive customer engagement. Following the changes in Star Ratings, the creation of a personalized, seamless experience across the customer journey that result in holistic engagement should be the end target for plans to realize the maximum benefits.

As competition in the health plan landscape intensifies over expanding their MA customer base, lowering the churn rate, and generating more revenue, efficiently leveraging analytics and automation solutions will become the key differentiator. Here are some ways users can gain a competitive advantage by using technology:

  • Deploying automation solutions to optimize call center operations that automate script/process tools and eliminate the repetitive tasks to support high-call volumes. This will allow human agents to dedicate more of their efforts towards high-priority customer segments to improve the customer experience and reduce operations cost
  • Leveraging analytics solutions such as customer journey analytics, channel analytics, and sales analytics to analyze customer history and behaviors for enhanced member segmentation and profiling. This will allow the plans to have seamless omnichannel outreach and engagement initiatives across different member segments

In the short term, existing analytics and automation solutions will need to be optimized and scaled to enhance customer engagement. Moving forward, customer analytics and automation will need to be integrated and deployed across the value chain of health plans to realize the full potential.

The ball is now in the court of health plans to capture this opportunity and turn the new Star Ratings in their favor by taking the right steps. While the outcome for health plans remains to be seen, these changes will certainly improve the member experience, especially at a time when delivery of high-quality healthcare services is a key priority.

To share your experiences on the CMS Medicare Advantage Star Rating changes, contact  [email protected] or  [email protected].

Healthcare Interoperability Is Coming – How Your Enterprise Can Navigate the New Rules | Blog

With the deadline for the first phase of the healthcare interoperability rule coming July 1, are enterprises fully prepared to accommodate the changes and the interoperability mandate as a whole?

Our three-part blog will guide your organization through the regulatory implications, implementation approach, and future opportunities. To learn more about the evolution of interoperability and the challenges enterprises face in deciphering the new regulations, read on.

After decades of trying, interoperability is getting closer.

The Interoperability and Patient Access final rule has provided the impetus needed to finally bring together data from healthcare payers, providers, and health information technology (HIT) vendors for patients to easily access information and coordinate their healthcare.

Announced in 2019 by the Centers for Medicare & Medicaid Services (CMS) and The Office of the National Coordinator for Health Information Technology (ONC), the final rule laid down definite protocols and data standards to comply with unified data transmission between members, payers, and providers.

Healthcare enterprises originally had until January 1, 2021 to implement the Interoperability and Patient Access final rule. However, concerns over COVID-19 led CMS to push back the deadline for meeting the requirements, giving them until July 1, 2021 to comply. The regulation has provided a necessary push to healthcare enterprises for building a strong IT foundation to spur smooth data transfer among stakeholders and healthcare organizations.

So, what’s the buzz about? What does healthcare interoperability mean?

Simply put, interoperability is the capability of healthcare systems and applications such as Electronic Health Records (EHRs), Electronic Medical Record (EMRs), and claims data management systems to converse with each other and have an effortless information exchange. The vision is for members and patients to be able to access their healthcare data at their convenience.

Healthcare enterprises have been trying to implement interoperable systems within their infrastructure for decades. But many challenges and restrictions regarding technology immaturity and technical and financial debt have restricted them from achieving full interoperability. This started to change in the early 2000s with technological advances and a legislative push toward interoperability.

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What changes are coming for healthcare enterprises and healthcare IT vendors?

To help healthcare enterprises achieve the goal of making health data accessible to members or patients from anywhere, CMS and ONC have put forward the following key provisions:

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What are the biggest challenges healthcare enterprises face to interoperability?

Below are the major hurdles enterprises will need to overcome to implement interoperability:

  • Misaligned incentives: The incentives of the stakeholders are misaligned with the goals of interoperability. For example, every HIT vendor currently sells proprietary systems. If interoperability becomes a reality, the customers will no longer encounter proprietary lock-in and will be free to choose any vendor. As a result, interoperability would dilute the competitive advantage of the HIT vendors and cannibalize their existing revenue streams
  • Complementary technology enablers: To avoid large upfront investment from each stakeholder, the entire technology framework might be cloud-driven. A host of APIs would need to be developed to enable information sharing between the common platform and the numerous proprietary databases currently used. Similarly, a secure API ecosystem would have to be implemented for external data sharing
  • Security of data: Enterprises might require third-party app developers to create their own branded applications for accessing health data. However, there is no regulatory authority over third-party apps and their use of protected health information. Also, with interoperability coming into play, the entire healthcare database might be located at one central platform, making it an easy target for cyber attackers

Interoperability is a journey and an opportunity for healthcare enterprises to assess and remodel their infrastructure. A strong interoperable infrastructure will ensure that healthcare enterprises reap the benefits of their current investments in the long term – enabling them to handle any future technology or industry changes.

To lead the industry, healthcare enterprises need to look beyond the areas defined in the regulation and also focus on a scalable, robust IT architecture, a security-led ecosystem, and the role of analytics in the long run.

To read more about interoperability and emerging opportunity areas in healthcare, read the next installations in our blog series, where we will talk about the interoperability framework and areas of investment for healthcare enterprises. Please feel free to reach out to [email protected] to share your experiences and questions.

The Prescription to Evaluating Telemedicine Is Using a Holistic Framework | Blog

Telemedicine became an essential tool for delivering healthcare services remotely during COVID-19. But was this growing trend of virtual doctor visits truly effective, and will it continue post-pandemic? Current evaluation systems present many limitations to determining how well telemedicine is performing. A more comprehensive framework is needed to get the RX to success. Read on to find out what is needed.      

With telemedicine adoption surging and gaining greater acceptance by physicians and patients, determining the quality of the services provided has become critically important. Moving ahead, providers must have satisfactory answers to such lingering questions as: How do you effectively evaluate telemedicine? What impact do all the stakeholders involved have in the evaluation?  Are the current evaluations extensive enough to cover all factors?

While telemedicine usage skyrocketed due to the unavoidable circumstances of the pandemic and provided many immediate benefits, we now need to understand if its usage will continue in the long term as normalcy returns.

In comparison to in-person visits, telemedicine is more complicated, especially when considering the additional stakeholder responsibility involved from payers, providers, policymakers, technology providers, and consumers.

Beyond the care outcome that is usually gauged in typical face-to-face appointments, such factors as implementation, delivery, and repeatability must also be rated to determine the true value of telemedicine.

The need of the hour is creating better, extensive, and holistic evaluation frameworks that take into consideration most, if not all, of the dimensions that affect the overall care and patient experience delivered virtually.

Obstacles to overcome

Telemedicine evaluation frameworks and methodologies have been evolving. However, the sluggish rate of telemedicine adoption and skepticism toward its practice until now has delayed the progress in creating a more comprehensive evaluation framework.

Also presenting obstacles to a more holistic approach are the considerable variations in focus areas and the narrow and isolated scope of evaluation, such as those only considering specific clinical areas, measuring patient satisfaction, evaluating technology, assessing cost and efficiency, etc., separately.

While piecemeal evaluations catering to specific aspects of the telemedicine continuum help gauge a particular aspect, they cannot effectively capture the wider and more complex horizons of telemedicine.

A better holistic framework that encapsulates all evident and latent aspects starting from defining the needs of telemedicine care to measuring long-term health and experience outcomes is needed.

Telemedicine evaluation elements

Telemedicine providers need to look deeper than healthcare outcomes and consider the more abstract elements like patient and provider satisfaction, usability, and repeatability. The framework currently used by the Institute for a Broadband-Enabled Society (IBES) uses patient control, clinical quality of care, organizational sustainability, and technology capabilities as its factors.

Another example of a framework, which stems from academic roots, uses an assessment model looking at three dimensions based on functionality (consultation, diagnosis, monitoring, and mentoring), technology (modes, network design, and connectivity), and applications (treatment modalities, medical specialty, disease types, and sites). All such frameworks tend to take a certain perspective of a technological lens or care-outcome focused framework.

Six areas to consider when building or updating telemedicine evaluations

A framework for evaluation must span across the entire gamut of possible action points while looking at all the potential barriers and bottlenecks. The below framework attempts to cover the many diverse factors that are indispensable to telemedicine’s success.

Key Elements: Holistic Telemedicine Framework

telemedicine

Everest Group (2021)

  • Medical and human – This includes looking at health outcomes, the number and type of medical conditions, the nature of medical services provided (diagnosis, treatment, wellness advice, etc.), and the spectrum of care provided. Also to be evaluated are all the interacting human entities that play a part in healthcare delivery, such as provider staff and expertise, non-medical staff, technical teams, support, and maintenance personnel
  • Behavioral – This covers the behavioral aspects of the patient/client and provider such as awareness, perception, satisfaction, acceptability, adaptability, and other elements that encompass how involved stakeholders respond and react to a telemedicine application should be rated
  • Organizational – All aspects defining and involving care provider, patient, payer, administration, and technology structure need to be graded. This includes evaluating the leadership, organizational culture, workflows, hospital information systems, teams involved, etc.
  • Technological and knowledge – Technology tools and the technical knowledge that enables telemedicine to thrive should be reviewed, including the information systems, databases, platforms, software, applications, security systems, and other technological infrastructures in use. Also to be rated are the knowledge constitutes of interoperability, data quality, systems speed/performance, maintenance, and support, etc.
  • Economic – Elements relating to the economic and financial aspects that include financial performance, investment returns, financing business, and economic impact are all aspects to take into consideration
  • Regulatory, legal, and compliance – Evaluation of resolutions involving reimbursements, state and federal laws, compliance, privacy issues, medical legalities, technological compliances, and other legal/regulatory issues are all factors to be looked at

Organizational leaders need to step back and look at the complex structure in addition to their individual functions to gain a holistic understanding and reach the larger goal of building a successful telemedicine practice.

By expanding the view to these key areas, organizations will gain a more accurate picture of the effectiveness of telemedicine and be able to determine whether it will be sustainable in everyday instances moving forward.

Everest Group’s recent research, Unpacking the Rise of Telehealth, captures key insights of the telehealth market, covering trends across adoption, technology, and service provider dynamics. Please drop us your thoughts and reach out to us for a conversation at [email protected] or [email protected].

Keys to Developing a Successful Population Health Management Strategy – Unified Data Can Provide Full Patient Picture and Improve Outcomes | Blog

The US spends more on healthcare than other developed countries but has the worst health outcomes of high-income nations. One solution for improving this dilemma is applying Population Health Management (PHM).

PHM is a process used to improve the health outcomes of the broader population by utilizing resources in predicting and preventing diseases, identifying at-risk clusters and those in need of proactive intervention, and promoting the health of the population through integrated care techniques.

The healthcare models of countries such as France, Germany, Italy, Spain, and Japan are carefully designed to control costs and produce better outcomes. Most healthcare enterprises in the US have now recognized this need and are taking mammoth steps to embrace population health initiatives.

Important data sets required for population health

The core of population health management lies in accessing and analyzing healthcare data, including claims data, data present in Electronic Health Records (EHRs), wearables, Social Determinants of Health (SDOH), and social media.

The key to developing a successful PHM strategy lies in being able to access all of this data rather than specific chunks. Different types of data sets come with varied challenges. While claims data is easily accessible, it lacks the details on behavior, outcomes, reactions, and responses that are needed to create an end-to-end picture of the patient.

Meanwhile, data available in EHRs is highly important in terms of insights but still difficult to access. Even with recent regulations, not all the data present in the EHRs that is relevant for clinical research will become accessible.

The end-to-end platforms available for PHM can integrate data across devices and aggregate and analyze this data to ensure access to a complete patient record, thereby enabling better decision making.

What are the current challenges to adoption?

Despite the advantages of PHM, interoperability and current reimbursement models present obstacles.

Population health management solutions rely on the underlying data to create significant health interventions. Healthcare data doubles every 80 days, yet most of this data isn’t accessible. A lot of the data in the EHRs is unstructured, which makes it difficult to extract. Even with the recent interoperability mandates from the Office of the National Coordinator for Health Information Technology (ONC), not all the data will become accessible. A lot of the research-grade data that is relevant for complex interventions won’t be accessible immediately and eventually will be rolled out.

Changes also are needed in reimbursement models. Current healthcare models are based on the principle of fee-for-service, which are more focused on promoting volumes and dealing with illness than delivering value by promoting overall health. There is very little incentive to implement preventative and holistic care strategies, engage with patients, and encourage them to take charge of their health.

Creating a successful PHM strategy

Here are a few measures that organizations can take toward PHM success:

  • Integrate PHM with the broader interoperability strategy – This will draw the maximum benefit out of the available pool of data. It is a journey that requires both long-term and short-term strategies that are informed by data
  • Take proactive steps to include risk-based contracts and bundled payment models – These are critical to first understanding the costs of care. This includes adopting value-based payments and understanding the cost implications in a population health management setting, which means looking beyond single episodes with patients
  • Actively invest in integrated care solutions – These integrated care solutions bring together all parties involved in delivering healthcare, coordinate their services by sharing information, and transform healthcare into a seamless experience for the patient. Increasingly, this care is moving away from emergency department visits and lengthy hospital stays to more accessible and less costly settings in homes, schools, and at work. Technology adoption is critical to delivering this level of “connected health”
  • Invest in patient engagement as an essential part of the broader population health strategy – This will help organizations capture and utilize patient-generated health outcomes data, enable patients to participate more actively in their health outcomes, make regular wellness initiatives a part of their daily routine, and further improve medication adherence

How have you planned your PHM strategy? To share your experiences and learn more about PHM, reach out to Priya Sahni, [email protected].

The Changing Face of the CRO: Becoming the Everything Store for Decentralized Trials | Blog

On February 24th, 2021 we saw an announcement of one of the largest mergers/acquisitions that the CRO space has ever witnessed. ICON, the Dublin-based global CRO, announced that it has entered into a definitive agreement to acquire rival North Carolina-based PRA Health Sciences in a deal valued at US$12 billion. The deal, which makes the combined entity the second-largest CRO, next only to IQVIA (itself a merger of IMS Health and Quintiles), is one of the many instances of the rapidly consolidating CRO industry, accelerated by COVID-19.

Pushing the gas on decentralized trials

While there are a lot of potential synergies in this acquisition, such as minimum overlap in terms of geography, deeper therapeutic capabilities, and broader service offerings, one important takeaway from this acquisition echoed by Dr. Steve Cutler, Chief Executive Officer of ICON, is the shift towards Decentralized Trials (DCTs).

With decentralized trials gaining importance, thanks to the pandemic, there has been an increasing focus from CROs to shore up their capabilities and develop an integrated solution. For instance, Bioclinca and ERT recently announced a merger that enabled the combined entity to provide holistic solutions in eCOA, imaging, and clinical trial management solutions. ICON, through this acquisition, has set out to achieve an integrated offering in DCTs as well. It seeks to combine its home health services, site network, and wearables technology with the mobile health and connected health platforms and other real-world data solutions from PRA Health Sciences.

Becoming the everything store for decentralized trials

Traditionally, a CRO was considered a business process service provider, managing trial operations in regulatory, safety, and clinical conduct. Very few offered technology solutions along with business process services as this was often considered the forte of product vendors such as Oracle Health Sciences and Medidata. However, with the pandemic halting clinical trials, stakeholders analyzed how to restart paused clinical trials by virtualizing certain components of the trials through some short-term fixes, such as use of eConsent and eCOAs solutions, resulting in an uptick in DCTs.

Initially, partnerships had been the preferred route for CROs to support DCTs, for example, the Covance partnership with Medable wherein Covance’s patient and site interface would be powered by Medable’s DCT offerings. However, the recent M&A activity suggests that CROs are now considering adding product capabilities to enable DCTs by acquiring product players (such as what Bioclinica did with ERT) or by acquiring CROs with strong technology capabilities to support such trials (such as ICON and PRA Health Sciences). The result – offering a one-stop-shop solution to support DCTs, as highlighted in the visual below.

Figure 1: A one-stop shop solution for supporting decentralized trials

A one-stop shop solution for supporting decentralized trials

The advantage of such an integrated solution is that it augments the CRO’s value proposition to conduct DCTs – integrating platforms, services, site networks, and data capabilities, all into one place. Such CROs can now provide patient recruitment, engagement, and retention services (which has traditionally been their stronghold) using the underlying DCT suite through which the patient can enroll, record clinical outcomes, and engage in video consultation with the doctors/physicians. Additionally, they can also provide auxiliary support services, such as the provisioning of devices used for remote patient health monitoring and offering home nursing services aimed at reducing or eliminating patient visits to trial sites, medical record review services to check for completeness, accuracy, and compliance of medical data, and remote CRA services to oversee the DCT.

Implications for CROs

While, at first, the advantages of an in-house DCT suite seem to improve the value proposition for the CRO, it is also pertinent to note that in this scenario, CROs are also competing directly with DCT product vendors such as Medable and Science 37. The key challenge for CROs would be in convincing clients who still hesitate, while adopting technology offerings given their business process services heritage.

CROs aiming to walk down the acquisition path should keep the following pointers in mind:

  • Innovate or perish: CROs would be competing directly with product vendors – an industry notorious for innovation. Investments aimed at improving the product quality, product enhancements, and fixing issues would be critical to win client trust
  • Incorporate success stories: Showcasing client success stories and case studies will reduce client hesitation to adopt the one-stop DCT solution and drive increased product uptake
  • Offer innovative commercial constructs: Traditional ways of contracting (for example, per study or volume-based constructs) may not work with DCTs. While offering clients a BPaaS construct, check for risk-sharing agreements as clients appreciate vendors who showcase skin in the game

Looking into the crystal ball

The DCT space is ripe for disruption and the string of M&A activities shows the increasing emphasis that CROs are putting on DCTs. As efforts to improve the value proposition intensity and innovation ensue, the industry can expect more tuck-in acquisitions and even some mega-mergers, such as ICON and PRA Health Sciences, to continue well into the future. What are your thoughts on this? Let us know at [email protected] and [email protected]

BioClinica and ERT to Merge: Perspectives on Potential Synergies | Blog

On December 10, 2020, ERT, a clinical end-point data solutions company, announced its merger with BioClinica, a clinical trial management and imaging solutions company. The goal of the resulting enterprise will be to integrate the best of both worlds – ERT’s expertise in electronic Clinical Outcomes Assessment (eCOA), therapeutic expertise in cardiac safety and respiratory, and clinical endpoint measurement through wearables, with BioClinica’s expertise in imaging and clinical trial management solutions. The merger will equip the combined company to deliver data analytics, insights, business intelligence, virtual patient visits, and technology solutions to its clients.

In analyzing this development, we’ve taken a look at the hottest topics in the life sciences industry right now – decentralized and virtual clinical trials.

Virtual clinical trials – a revolution catalyzed by the pandemic

A virtual clinical trial is one in which certain parts of the clinical trial are conducted outside a clinical site, such as patient consent capture, trial data capture, or patient monitoring through sensors or wearables. The benefits to the pharmaceutical company include cost savings, better patient recruitment and retention, and improved data quality.

Earlier this year, we published a blog predicting that the 2020s would be the decade of virtual trials. It seems we were way off the mark – by about nine years. The year 2020 has already seen its fair share of virtual trials, as clinical trials that were put on pause due to lockdown restrictions were rescued by being converted to fully virtual or hybrid trials, such as cases in which clinical experts visited patients at their residences to collect vitals or samples, reducing delays.

#NoGoingBack

The virtual trial momentum isn’t temporary, and there’s increasing focus on virtual trials, even among investors. Not only this, many in the industry have pledged to preserve the progress they’ve made in clinical research due to the pandemic, including virtual trials.

On the same day the news of the merger was announced, the Decentralized Trials & Research Alliance (DTRA) was formed to unite stakeholders with a mission to make clinical trial participation widely accessible by advancing policies, research practices, and new technologies in decentralized patient-focused clinical research. Companies that are part of this alliance include technology vendors such as Medidata Solutions and Oracle Health Sciences, pharma companies such as Pfizer and Roche, CROs such as Parexel and Syneos Health, and others such as Amazon and the US Food and Drug Administration.

M&A and investment activity has increased, too. For example, Medable and Science 37 each received funding during the pandemic to advance their virtual trial offerings. And in November 2020, VirTrial, a telehealth platform for managing decentralized and virtual clinical trials, was acquired by Signant Health, a Clinical Trial Management System (CTMS) vendor, thus augmenting its virtual trial capabilities.

Clearly, virtual trials are a ripe area for M&A and investment activity given their disruptive capabilities and benefits. And we continue to expect more acquisitions, funding, and collaboration in this space in the near future.

What this all means for the merger

Our recently concluded PEAK Matrix assessment on clinical development platforms pointed out that BioClinica’s Cloud platform for clinical development does not have the capability to support virtual trials; we said it needed to invest in remote monitoring and eCOA capabilities to deliver on virtual trials. However, the solution does have a broad set of capabilities in the clinical, regulatory, and safety value chains.

As a result of the merger, however, BioClinica will be able to offer virtual trial capabilities to clients. ERT is one of the leading eCOA providers and through its wearable and sensor data capture capabilities, it is well positioned to conduct virtual trials in certain therapy areas. And it will be able to use the BioClinica Cloud offering to give clients a holistic clinical development experience, a win-win-win for ERT, BioClinica, and their clients.

Exhibit 1 shows the combined solution landscape.

Exhibit 1: The merger synergies

bioclinica

The merged entity will be able to showcase an end-to-end clinical development platform with enabling layers for virtual trial conduct. This move is definitely the right direction, at the most opportune time, and is just another sign of increasing interest in decentralized and virtual trials.

What are your views on this merger? Let us know your thoughts at [email protected] and [email protected].

Health Insurance Open Enrollment Period (OEP) 2021: Key Changes, Challenges, and Opportunities | Blog

“It is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change.” – Charles Darwin

Charles Darwin’s famous words aptly describe what healthcare payers need to do in the times of COVID-19. The pandemic’s disruptive nature has forced the industry to accelerate adoption of many concepts –  such as telehealth – that had earlier been considered at least half a decade away from becoming mainstream. The changes that the US Centers for Medicare and Medicaid Services (CMS) has proposed for the health insurance Open Enrollment Period (OEP) 2021 are a clear indicator of these transformative times. The objective of these changes – such as the expansion of telehealth coverage, more transparency through regulations such as the Interoperability and Patient Access rule, and changes in risk adjustment / star ratings calculations – is accelerating the CMS toward its goals of universal coverage, transparency, member satisfaction, interoperability, and resilience.

As the OEP is a time when healthcare payers strategize about how to increase their enrollment numbers (in the short term) and achieve operational and business transformation (in the long term), it is imperative that payers not only understand the upcoming changes but embrace them through the right investments. OEP 2021 becomes effective November 2020, so healthcare payers are in the midst of the planning season.

In this blog, we take a look at the key changes CMS has proposed for OEP 2021 and analyze their impact on healthcare payers.

Exhibit 1: OEP 2021 proposed changes

Key changes suggested by CMS for OEP 2021

The impact of CMS-proposed changes on healthcare payers

CMS’ recommended changes for OEP 2021 are likely to impact healthcare payers in multiple ways:

  • Shift in membership and profit pools: The change in healthcare payers’ membership bases due to factors such as rising unemployment (which has reduced the employer-sponsored plan base) and the enrollment of End-stage Renal Disease (ESRD) patients in Medicare Advantage (MA) plans is likely to increase healthcare payer costs.
  • Member transparency and control measures: OEP 2021 has a slew of changes aimed at ensuring transparency through data sharing with members/patients via APIs and third-party apps. These changes include mandating the use of Real Time Benefit Tools (RTBT) for Part D plans and rules requiring plans to disclose the measures used to evaluate network pharmacy performance. It is clear that the CMS wants health plans (particularly MA Part D in this case) to invest in technology, data sharing, and reporting to enable the next phase of member-centricity in healthcare.
  • Medical Loss Ratio rebates support: Administrative Loss Ratio (ALR) / MLR has always been a pain point for healthcare payers, as an unfavorable ratio implies refunds and complex readjustments. With the CMS offering some rebates to payers in terms of how they calculate MLR, payers are likely to invest in improving care delivery initiatives.
  • CMS reporting dilemmas: With the CMS pushing healthcare payers to share actual member/patient experience data for Star Ratings and Risk Adjustment score calculations, healthcare payers will need to invest more in member satisfaction.
  • Shifts in health plan benefit inclusions: Telehealth services are only one set of inclusions that payers need to think about incorporating in plan benefits. Many other areas merit attention, such as member support, personalized communications, reorganization of provider network, and plan tiering.

How can payers navigate the changes and what are the likely sourcing implications?

While OEP 2021 is just another milestone for the CMS to drive healthcare efficiency, it is also notable that the changes are happening in the backdrop of the COVID-19 pandemic. The timing presents healthcare payers with both challenges and opportunities. In fact, industry experts believe that if ever there was a time for payers to change, it is now. This means that payers need to prepare strategies quickly to navigate the CMS-proposed changes, as well as changes arising from the COVID-19 disruption. The strategies will, in turn, lead to changes in their sourcing practices, thereby creating opportunities for outsourcing them to service providers.

Exhibit 2 lists the strategies that, we believe, healthcare payers will adopt in the coming months and the sourcing implications for each of them.

Exhibit 2: Payer mitigation efforts and sourcing implications

Payer mitigation efforts and sourcing implications

For the outsourcing and third-party vendor community, this is the right time to help mitigate the impact of OEP 2021 and the pandemic on healthcare payers. Service providers should align their offerings with payer needs.

If you’d like to know more about OEP 2021 and its wide-ranging impact, please read our recently published viewpoint Open Enrollment 2021 Primer: What to Expect and How to Navigate in the Wake of COVID-19. You can also reach out to me directly at [email protected] if you have any questions or observations.

The Teladoc-Livongo Merger: US$18.5 Billion Deal Heralds Virtual Care’s Breakout Moment | Blog

The Blockbuster Merger

The August 5, 2020, announcement of the US$18.5 billion mega-acquisition of Livongo – a chronic disease management company – by Teladoc – a multinational telemedicine and virtual healthcare company – rocked the virtual healthcare industry with seismic shockwaves.

Both companies had posted strong revenue growth before the acquisition. Teladoc’s revenue grew by 85% (or US$241 million) in Q2 2020. In the same quarter, its visits rose by more than 200% YoY to 2.8 million. Livongo’s revenue for the quarter grew by 125% YoY, bringing it to $91.9 million, with enrollments increasing 113% YoY to reach 410,000 members. The merger results in one of the world’s largest virtual health entities, with a combined valuation eclipsing US$37 billion.

The Mutual Strengthening

The importance of telehealth in a pandemic-stricken world became evident as the crisis overwhelmed providers (as it did other businesses), forcing many to close and postpone nearly all elective, low priority, and non-emergency appointments. To address ongoing health challenges, a significant portion of care provision shifted to virtual models, bringing companies like Teladoc to center stage. Digital healthcare and virtual health have since had an unprecedented surge in interest, investment, and adoption around the world.

The Teladoc-Livongo merger strengthens many facets of virtual healthcare delivery, which could benefit healthcare providers/facilities and patients. It is also evidence of the ever-growing complexity of engagements and constructs shaping virtual care.  The resulting organization will be able to realize multiple benefits given synergies between the two companies:

  • Teladoc will benefit from Livingo’s analytics prowess, which is delivered through its Applied Health Signals offering. The strong fundamentals of the data-driven approach underlying Livongo’s behavioral change and chronic management offerings can enable Teladoc to add significant value by layering its existing products with the acclaimed technology to provide its patients with tailored, efficient, and effective programs.
  • Livongo’s patient base will have access to a larger pool of healthcare professionals, who can provide more in-depth care and help diagnose and care for other ailments beyond the current set of offerings. The additional medical practitioners from multiple clinical specialty areas will enhance care delivery, improve options available to patients, enable access to a wider set of services, and eventually improve healthcare outcomes.
  • Patients will have access to a more integrated and comprehensive care experience given the expanse of virtual care segments the combined entity will offer.
  • Beyond the expanded pool of care professionals, both companies bring their own partnerships with health plans, employers, and other care-specific partners to the relationship, providing significant cost and coverage benefits to existing and future enrollees.
  • The combined entity will be able to increase its global footprint and benefit from cross selling services to an expanded client base, especially at a time when the adoption curve for virtual care is at the precipice of significant growth.

The Road Ahead

The era of digital health has been long coming, and the COVID-19 pandemic has only exacerbated the need for virtual care. This merger sets the stage for future growth, particularly in areas such as remote patient care, remote monitoring, remote diagnostics, digital-led triaging, digital therapeutics, self-care, and others that will revolutionize the care experience.

The industry has crossed an inflection point beyond which lies an extremely dynamic and unpredictable path, which requires healthcare entities to stay nimble, rethinking care models and care delivery through remote technologies. Healthcare payers and providers must quickly adapt to the shifting landscape and adopt the necessary digital means to stay competitive and become competent.

To find out more about the growing interest in and adoption of telehealth services, see our report Unpacking the Rise of Telehealth and reach out to [email protected] with your thoughts.

Data Monetization in Healthcare | Blog

A form of monetization, data monetization refers to the use of an organization’s data as an economic asset to reduce costs and increase business value. Organizations can monetize their data by providing third parties data access, commonly referred to as direct monetization, or by using the insights derived from this data to improve their internal processes, known as indirect monetization.

One industry that has seen an exponential rise in data in recent years due to increasing digitalization is healthcare. Health records are increasingly moving to the cloud, and the use of wearables and smartphones has become almost ubiquitous. This digitalization has paved the way for data monetization in healthcare, and it is helping not only to improve clinical services but also realize financial benefits. A strong integration of data with technology is set to revolutionize value-based care and personalized medicine and introduce better care outcomes.

Let’s take a closer look at how data monetization, particularly direct monetization, works in healthcare.

Bilateral data exchange – Among the earliest data monetization models, bilateral data exchange enables organizations to sell their data to one or more parties. It has experienced high adoption over the years, but its scope for disruption is limited, as single entities become data owners, and there is no data-based innovation at an industry level. Such data exchange is also mired in controversy, as highly sensitive patient data flows freely between organizations.

A case in point is the deal inked between Google and Ascension in November 2019 to provide Google access to millions of Americans’ health records. It came under the US Department of Health and Human Services’ regulatory scanner just 48 hours following its announcement.

Open platforms for data exchange – In this model, data providers can sell their data to platform owners, while enterprises can test their innovations using the platforms. The platform owners become data custodians in this case. This model has high potential for disruption, as it facilitates industry-wide collaboration for data transfer. It is gaining popularity among innovators, researchers, and academic institutions for early-phase testing of new products.

Mercy Technology Services’ (MTS) Real-world Evidence (RWE) network is one such open platform. MTS combines large data sets generated by health systems with advanced analytics, and provides insights for thousands of medical products that make it to the market every year. The RWE network allows medical product firms to test their products in real-time and providers to test their clinical decisions to offer better patient care.

Open marketplaces for patients to sell data – The most controversial aspect about data monetization is the sale of patient data without obtaining patients’ consent. Patients are the ultimate owners of their health data, and thus it is highly debatable whether large organizations should be allowed to make money by selling or buying this highly confidential data.

Open marketplaces for patients allow them to directly sell their health data to any party interested in buying it. Open Health, for example, has launched a platform that allows patients to monetize their health data by connecting companies or research institutions with people who fit the criteria for different studies or analytics. Users can share their health records with pharmaceutical companies, health systems, and insurers for a fee. This model is gaining popularity due to secure data exchange practices, and as it helps resolve the ownership and privacy concerns accompanying other models

Open marketplaces for data exchange – In such marketplaces, data providers can sell data, while interested entities can find and access relevant data. The seller retains the ownership, and buyers simply obtain the permission to subscribe to this data. This model serves as a bridge between organizations that possess a significant amount of healthcare data and those that need it. Amazon Web Services (AWS) Data Exchange is one such open marketplace that allows AWS customers to browse through and purchase a variety of data sets offered by data sellers

In our opinion, this model has the highest potential to disrupt the data monetization market in the coming decade, as it facilitates industry-wide collaboration for data asset exchange.

It is, thus, amply clear that in their quest for data, organizations can’t afford to ignore the need to ensure data privacy. The US Health Insurance Portability and Accountability Act (HIPAA) establishes national standards to protect individuals’ medical records and other personal health information. It applies to health plans, healthcare clearinghouses, and healthcare providers that conduct certain healthcare transactions electronically. The debate around data privacy is likely to get fiercer in the coming years, and only data monetization models that can address this challenge are likely to succeed.

What has been your experience with data monetization? If you’d like to discuss your experience or data monetization and how it applies in healthcare, please reach out to [email protected] or [email protected].

 

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