Tag: healthcare and life sciences

Life Sciences Supply Chain Visibility: A Strong Link in the Chain | Blog

Improved supply chain visibility can help global pharmaceutical and medical device suppliers overcome the many logistics challenges they face post-pandemic. Internet of things (IoT) and blockchain technologies offer promise to address the growing demand for product traceability and transparency. Read our second blog in this series to learn more.

The COVID-19 pandemic exposed major supply chain weaknesses in the life sciences industry as the industry experienced skyrocketing demand for innovative medical products.

Enterprises struggled to keep operations running amid the pandemic without adequate supply chain product visibility or unified systems to provide needed data to improve logistics performance.

Most companies lack the analytical tools to completely integrate and analyze data from various systems at all levels – from the plant’s local work centers to the world’s end-to-end supply chain.

As a result, the massive data generated during the pandemic provided little usable information and insights.

Supply chain visibility: right time for real time?

Supply chain visibility can help enterprises overcome these challenges and build more robust and effective supply chains by tracking medical products in transit and providing a clear view of the inventory and activity.

Let’s look at the factors that are driving enterprises to invest in supply chain visibility.

  • Product loss and recall: Theft is costly to the industry and needs to be stopped. The pharmaceutical industry experienced its largest theft in 2020 when $1.2 million worth of oncology drugs were stolen from a cold storage warehouse. In the second largest theft that year, $600,000 in pharmaceuticals were taken from a distributor.

 The industry also is being hit by losses due to expired, non-compliant, or recalled products that have problems with temperature parameters or other issues. According to the U.S. Food and Drug Administration (FDA), 281 drugs and 50 medical devices were recalled during the two years of the pandemic

  • Counterfeit products: Increasing numbers of fake drugs and medical devices have found their way into customers’ medicine cabinets. Counterfeit drugs are valued at an estimated US$200 billion annually. Since the World Health Organization (WHO) established a global surveillance and monitoring system in 2013, it has received 1,500 reports of substandard or falsified products. Of these, antimalarials and antibiotics are the most reported. Geographically, 42% come from the African region and 21% each from the Americas and Europe.

Local regulatory frameworks are being implemented to provide more product visibility. For example, the Indian government has mandated life sciences enterprises include Quick Response (QR) codes on Active Pharmaceutical Ingredients (APIs), effective January 2023

  • Regulatory frameworks: The Drug Supply Chain Security Act (DSCSA), amended by the FDA in 2013, mandates enterprises to create an electronic system to track and trace certain prescription drugs. Manufacturers and trading partners are required to encode their products with unique identifiers on the individual packages and track products at the unit level by November 2023.

Similarly, the European Union (EU) Medical Device Regulation (MDR), which regulates the production and distribution of medical devices, mandates MedTech enterprises place a Unique Device Identifier (UDI) for better visibility and tracking of products across the supply chain

A recent analysis found the top 15 global pharmaceutical companies emit 55% more greenhouse gas emissions per million dollars of revenue than the automotive sector. Medical waste has also become a significant issue, particularly with the spread of single-use personal protective equipment and testing kits. As a result, life sciences enterprises are taking initiatives to build more transparent supply chains to track and trace carbon emissions, medical device decommissioning, and secondary package waste

Everest Group’s view of end-to-end supply chain visibility solutions

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Let’s explore more on the supply chain visibility framework:

  • Make/Manufacture – Inbound logistics that includes procuring raw materials, drug packaging, and moving finished goods to the supply chain

Use Cases: Addressing drug serialization and aggregation, strategic sourcing, fleet tracking, drug e-labelling, artwork management, and API tracking

  • Deliver – Outbound logistics that include order confirmation, shipping, last-mile delivery, and customer service

Use Cases: Addressing drug expiry monitoring, network management, demand forecasting, and warehouse management 

  • Stakeholders experience – Unifies vendors, suppliers, distributors, pharmacies, patients, and others in the life sciences supply chain with one platform 

Use Cases: Asset tracking, anomaly detection, and condition monitoring alerts

  • Returns management: Communicating with end-customers, stakeholders, and life sciences enterprises to obtain and restock goods. Having visibility of goods in reverse logistics helps enterprises make calls on whether to discard, repurpose or recycle drugs and medical devices

Use cases: Case and compliance management, returns tracking and scheduling, conditional monitoring alerts, and drug serialization

Service provider landscape

IT service providers are increasingly offering solutions to address these needs as these instances gain traction. One example is HCL’s serialization and authorization solution that helps track product returns in real time.

Recognizing the need for greater insights into supply chain performance, enterprises have invested in Enterprise Resource Planning (ERP), Laboratory Information Systems (LIMS), Electronic Batch Records (EBR), Manufacturing Equipment Systems (MES), Quality Management Systems (QMS), and other IT systems to capture transactional and performance data.

Information sharing, data interoperability, security, and trust are the major hurdles for life sciences enterprises to implement supply chain visibility solutions. Blockchain and the Internet of Things (IoT) offer promising prospects to tackle these challenges by maintaining the continuity of information, realizing the link between physical and information flow, and providing fraud detection alerts.

IBM, KPMG, Merck, and Walmart successfully completed an FDA pilot program in 2020 that found blockchain technology can be used to meet the DSCSA requirements to track and trace prescription drugs and vaccines distributed in the U.S.

We recommend life sciences enterprises partner with IT service providers that have point solutions for supply chain visibility or engage with niche platform providers to build end-to-end supply chain visibility solutions.

Keep following this space as we explore the technology in supply chain visibility platforms, and see our prior blog on Five Factors Transforming the Life Sciences Supply Chain and Creating IT Opportunities.

What are your views on life sciences supply chain visibility? Reach out to [email protected] and [email protected] to discuss.

You can also learn about planning for a sustainability in your organization in our webinar, Sustainability and the CIO’s Office: A Powerful Connection.

Five Factors Transforming the Life Sciences Supply Chain and Creating IT Opportunities | Blog

Supply chain visibility, strategic sourcing, cold chain requirements, sustainability demands, and personalized medicine are creating opportunities in the life sciences supply chain for IT partners delivering digital solutions. Read this first part of our blog series to understand the shift that is underway.

New security requirements, industry mandates, and changing customer needs require the contemporary life sciences supply chain to become more efficient, transforming the logistics network.

The worldwide value of pharmaceutical goods traded has grown six-fold in the past two decades from US$113 billion in 2000 to US$629 billion in 2019, according to the United Nations Comtrade Database.

This growth has driven more companies to outsource production to Contract Manufacturing Organizations (CMOs) to meet the pent-up demand. Let’s explore the factors impacting these increasingly global and complex chains.

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  • Pandemic-driven supply-demand fluctuations: Rising consumerism and pandemic-driven proliferation of precision medicines, wearables, and telehealth applications have left enterprises struggle to meet increased demand. One example of this is Bristol Myers Squibb’s struggling to meet the strong demand of BCMA-targeted CAR-T cell therapy Abecma
  • Ever-changing regulatory oversight: Many industry-wide regulations have been implemented to strengthen the safety and effectiveness of medical devices and drugs commercialized across the globe. These include the European Union Falsified Medicines Directives (EU FMD) in 2011, Drug Supply Chain Security Act (DSCSA) in 2013, European Union Medical Device Regulation (EU MDR) in 2017, and the UK Medicine and Medical Devices Act (MMD) in 2021
  • Need to reduce product diversion and recall: Increasing numbers of black-market activities and illegal drugs are finding their way into the supply chain and affecting companies’ brand values. The most common drug diversions are class benzodiazepines, opioids, stimulants, antipsychotics, anesthetic drugs, and GABA agonists
  • Supply chain data sharing and data security: Broad threats, ranging from cybersecurity to data breaches, have led to unplanned financial and intellectual property losses. A case in point: IBM detected cyberattacks against the cold chain drugs specifically associated with GAVI, the vaccine alliance, and government agencies involved in the drugs’ distribution

Five key investment areas in the life sciences supply chain

  1. Supply chain visibility: Implementing visibility platforms could have saved 1 billion vaccines during the pandemic, according to the United Nations Environment Programme. This creates opportunities for IT service providers to partner with enterprises to enable end-to-end supply chain track and trace models.

Additionally, the Drug Supply Chain Security Act (DSCSA) outlines requirements to achieve interoperable, electronic product tracing at the package level to identify prescription drugs distributed in the United States by November 2023. Similar laws are in effect in Europe and other parts of the world. (For more on supply chain visibility, see our next blog.) 

  1. Strategic sourcing: With the growing awareness post-pandemic of the supply chain risk of overdependence on raw material procurement from India and China, enterprises are starting to reshore pharmaceutical manufacturing in the US and Europe. 

Also, since sourcing and procurement account for roughly half of drug development and manufacturing costs, firms are focusing on optimizing spending by using technology to gain real-time spending views, structure budget accountabilities, and align purchasing with production

  1. Emerging cold chain requirements: Various factors have pushed enterprises to increase their focus on temperature-sensitive drugs that contain high-value active ingredients and have shorter shelf lives. Cold chain adoption also has been accelerated by the rapid growth of consolidated distribution houses and online retailers’ improved last-mile connectivity 
  1. Sustainable supply chains: The growing importance of sustainability initiatives is evident from the surge we have seen in Environment, Social and Governance (ESG) report. ESG funds in biopharma companies increased 27% in 2021 from the prior year.

Sustainable secondary packaging, carbon footprint tracking, responsible raw materials procurement, effective medical device decommissioning, and scrap minimization are gaining more traction in the life sciences industry. Additionally, the European Union directive 94/62/EC, in conjunction with directive 2018/852, demands a significant reduction in packaging waste by 2025 

  1. Supply chain tailored to personalized medicine: Specialized logistics partners are needed to handle the extremely delicate and patient-specific components of innovative and personalized medications – from collecting cells/genes from healthy donors to delivering innovative medicine to patients.

Life sciences enterprises have invested approximately US$ 13 billion in cell and gene technologies since 2018. More than 900 enterprises worldwide are developing cutting-edge advanced therapeutics, and approximately 1,000 advanced therapy clinical trials are underway. This changing landscape requires supply chains that provide temperature-sensitive environments, closed loops, Chains of Identity (COI), and Chains of Custody (COC)

Implications for service providers

In response to these factors, next-generation connected supply chain ecosystems are beginning to emerge. Life sciences enterprises will need the right complementary digital technologies to optimize costs, drive productivity through streamlined route selection, and improve the customer experience.

This will create new opportunities for IT service providers that bring niche talent and a balanced portfolio of engineering and digital services, as well as supply chain-specific platform providers who will become partners of choice for life sciences enterprises.

Follow the second part of this blog series as we explore supply chain visibility platforms and enterprise initiatives.

To share your views on the life sciences supply chain, please reach out to [email protected] and [email protected].

For more details on the service provider outlook, watch our webinar, Outsourcing Services Pricing: What to Expect Next.

Increased Deal Activity in Revenue Cycle Management (RCM): What is the Winning Formula? | Blog

Health systems are increasingly seeking competitive proposals post-pandemic to outsource Revenue Cycle Management (RCM) and get the best prices and innovation in contracts. Learn what enterprises want and how providers can win these RFPs. 

Why has outsourcing gained traction in the Revenue Cycle Management (RCM) market?

The hospital revenue cycle process was not immune to the many changes COVID-19 brought to the US healthcare provider ecosystem, causing health systems to significantly shift operations to survive.

Challenges such as financial pressure, regulatory changes, the quality care and patient experience focus, and digital penetration pushed health systems – who traditionally prefer to keep operations in-house – to look outside for support. This drove more than 10% year-over-year growth in sourcing in the RCM market in 2021, and the strong contracting activity continues to gain traction this year.

Several health systems, including MarinHealth, Baptist Health, SSM Health, and Bassett Healthcare, have entered into outsourcing agreements with third-party vendors. However, unlike most past arrangements when sole-source was the dominant sourcing model, RFP-led sourcing is now the preferred model for healthcare providers in the post-pandemic world.

Exhibit 1: Split of new Revenue Cycle Management (RCM) services deals in 2021 – sole-sourced versus RFP-led

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Source: Everest Group’s coverage of 32 major RCM services outsourcing providers

Why do healthcare providers prefer RFPs?

Key factors driving health systems towards a competitive route over sole-sourced are:

  1. Unlike the pre-COVID era, when outsourcing was, typically, limited to a revenue cycle function or segment, the new deals coming in the Revenue Cycle Management (RCM) market are broad-based and many times encompass the end-to-end revenue cycle needs of healthcare providers. Given the size and scale of such deals, healthcare providers prefer the competitive route to get the best possible deal
  2. While cost used to be the primary decision-making driver, health systems are now emphasizing deal aspects such as innovative pricing (wanting third-party providers to have skin in the game) and offering diversified delivery network, innovation pool commitment, and compatibility with existing infrastructure, including experience of working with platforms such as Epic
  3. With hundreds of outsourcing providers in the RCM market, health systems know they can shop around to get the best deal

Key decision-making parameters for health systems in a competitive bid

Healthcare provider enterprises are looking for service providers who can provide end-to-end services covering the entire gamut of Revenue Cycle Management (RCM), rather than discrete, siloed services.

From a decision-making perspective, below are some of the key parameters that enterprises look for when selecting a potential service provider, along with their relative importance rated on a scale of 1 to 10:

Exhibit 2: Level of importance of key buyer decision-making parameters for outsourcing Revenue Cycle Management (2021)

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Source: Everest Group’s coverage of major Revenue Cycle Management (RCM) providing enterprises

Service providers need to pay special attention to how they position themselves effectively in the extremely competitive RCM market. The two main levers determining a winning proposal are:

  1. High-quality, well-structured proposals that demonstrate a deep understanding of the client’s needs
  2. Commercial proposals that are well aligned with the client’s budget and offer flexible payment terms

 

As competitive RFPs rise in the RCM market, providers who can create a differentiated value proposition and align their strategies with the enterprise’s vision will succeed in securing these lucrative deals.

To discuss Revenue Cycle Management (RCM) reach out to us at [email protected], [email protected], or contact us.

Learn more about RCM operations in the healthcare industry in our video, Revenue Cycle Management RCM Operations – Emerging Opportunities & Strategies.

Understanding Strategic Investments by Decentralized Clinical Trials (DCT) Product Vendors | Blog

COVID-19 put the spotlight on Decentralized Clinical Trials (DCTs) that will last well beyond the pandemic-stricken years as the industry increasingly adopts digital solutions for conducting remote, virtualized, or decentralized trials. In this digital ecosystem, vendors need to focus on several strategic areas to provide a holistic DCT experience and stay ahead of the competition. Discover in this blog the five priorities that can help product vendors take the lead in the DCT ecosystem.

Decentralized clinical trials rose to popularity during the pandemic. As people around the world were advised to stay indoors, sponsors and Clinical Research Organizations (CROs) scrambled for an alternative solution. DCTs catapulted to the mainstream and disrupted the clinical trial landscape.

DCTs offer reduced dependency for on-site visits, increased patient convenience, and improved insights from real-time patient data. While the pandemic may slowly subside with increased vaccinations, decentralized trials are here to stay – continuously elevating the trial experience for patients, sponsors, and investigators.

Everest Group’s Decentralized Clinical Trial Products PEAK Matrix® Assessment 2021 found improving patient recruitment and retention are the top reasons behind sponsors adopting DCT solutions.

With DCT adoption growing significantly, sponsors have varied sourcing criteria based on their priorities. We have observed that large biopharma companies prefer a unified platform while mid-and small-sized players are more interested in cost as their top sourcing criteria for DCT vendors.

Biopharma companies want vendors who feel the market pulse and offer tailor-made deal solutioning for increased DCT adoption, as illustrated below.

Sourcing criteria for selecting DCT vendors

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Five focus areas for DCT vendors to enhance their value proposition

To increase DCT adoption and run trials holistically, sponsors and CROs require matured technology products as well as auxiliary services. Hence, DCT vendors should not only strengthen their product offerings but also up their game in delivering auxiliary services.

With the exponential rise in DCT adoption, new players are rapidly entering the DCT landscape. In this marketplace, how can vendors offer value and stay on top of the competition? Our analysis reveals the following five areas that can help DCT vendors elevate their offerings above others:

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  • Inorganic growth – Considering the speed of digital disruption in the clinical trial landscape, inorganic growth is the fastest way to grow and expand capabilities. Technology-based DCT product vendors are focusing on improving their consultative positioning by combining high-tech and high-science under one platform. Two recent examples are THREAD acquiring Modus Outcomes, an organization that supports eCOA selections, designs patient-centric trials, and fosters scientific delivery of DCTs. Similarly, Clinical Ink acquired Digital Artefacts to enrich the data coming from patient-reported outcomes with situational awareness and active and passive digital assessments

 

  • Partnerships – DCT product vendors increasingly seek to partner with specialists to enhance the delivery of auxiliary services. These unions aim to increase trial efficacy and eliminate risks and delays while improving the experience for patients and site practitioners. Some recent deals include Science 37 collaborating with Foundation Medicine to accelerate the patient selection process for oncology trials. THREAD has entered alliances with Almac Clinical Technologies to reduce trial delays and risks and also with endpoint Clinical to simplify trial operations for site personnel

 

  • Human capital development – Investments in human capital are either focused on designing a simple unified platform for seamless patient experience during trials or on expansion and marketing operations. This has led product vendors to add new positions like Chief Growth Officer, Chief Design Officer, Chief Strategy and Expansion Officer, etc. Medable, Science 37, THREAD, Castor, and ObvioHealth have made significant investments in hiring or opening multiple roles directly or indirectly related to DCT solutions to expand their services and establish strategic partnerships

 

  • Funding – Multiple DCT vendors have raised significant funding to enhance their DCT program. Science 37 has recently become a public-listed company, thereby making enough funds available for DCT expansion and growth. On the same lines, Medable has secured a US$ 304 million Series D funding, taking the total company valuation to just over US$ 2 billion. It plans to use the funds to improve access to clinical trials worldwide and accelerate new drug development. ObvioHealth had raised US$ 31 million in its latest round of funding, while Castor raised US$ 45 million in its series B funding. While ObvioHealth plans to direct funding to enhance its proprietary IT capabilities and make new hires, especially keeping in mind the APAC region, Castor is focusing on accelerating trials and maximizing the impact of research data on patient lives. These activities clearly echo the positive investor sentiments towards DCT solutions

 

  • Geographic expansions – Enterprises are looking for studies that are global or beyond the North American (NA) region, pushing DCT vendors outside their established geographies into the Europe, Middle East, and Africa (EMEA) and Asia Pacific (APAC) markets. Both THREAD and Medable have established offices in Dublin, Ireland to expand their presence and grow the market for decentralized trials in the EMEA region. ObvioHealth has partnered with Anatara Lifesciences to launch DCTs in Australia, and Science 37 has partnered with CMIC Holdings to enable and advance its DCT offerings for Japan and the APAC region

The age of decentralized trials has begun, and sponsors are shifting away from the site-anchored approach to hybrid or completely decentralized trials. They are looking to convert their piecemeal deployments into a comprehensive strategy aimed at enhancing the trial experience for patients, sponsors, and CROs.

To cater to this rising demand, DCT product vendors need to leverage advancements in digital technology and enhance their value proposition. With a deep focus on inorganic growth, partnerships, human capital, funding, and geographic expansions, providers can offer a seamless DCT experience in 2022 and well into the future.

What areas should product vendors focus on to stay ahead in the DCT ecosystem? Reach out to [email protected] and [email protected] to discuss.

Explore more information about DCT adoption trends and providers. Learn more

The Future of Decentralized Clinical Trials Starts with a Patient-first Design Approach | Blog

The biggest benefit of Decentralized Clinical Trials (DCT) is the opportunity to enhance the patient experience, but the process is rife with challenges that create disengagement. The problem is not that patients are unengaged, but rather the vendor products are not always very engaging. The solution lies in undertaking a patient-first approach. Discover the tenets of a patient-first design approach in this second blog in our continuing coverage of this timely topic.

The pandemic has propelled decentralized clinical trials (DCT) into the mainstream, and multiple enterprises have transitioned into the virtual model for conducting clinical trials. Both enterprises and DCT vendors have stated that improved patient experience is the biggest benefit of the decentralized model. What do enterprises mean when they talk about patient experience? Read our blog, How Decentralized Clinical Trials Put the Patient Experience at the Forefront, to find out.

To deliver a superior patient experience and derive maximum benefit from this model of conducting trials, enterprises and vendors must be aware of the patient-facing challenges that might pose major hindrances. A closer look at the top challenges will help businesses develop effective measures to improve patient engagement and retention.

Major patient-facing challenges

The entire remote model has reduced in-person interactions. Insufficient communication from sites and sponsors often leads to disengagement among patients. The human touch, an important psychological aspect in healthcare, goes missing in this model. Added to this is the burden of learning about new products and technologies.

Patients have very limited digital literacy and may find it extremely difficult to operate a new sensor, a smartphone, or an application. Vendors are struggling to develop  robust training and support programs while enterprise buyers are more concerned about patient education capabilities and post-implementation support in their sourcing criteria.

All these factors create a general sense of discomfort and disengagement among patients, thereby defeating the principal benefit that vendors and enterprises expect from a DCT solution.

How can vendors overcome patient-facing challenges?

Designing a patient-centric solution is the best way to address these challenges. Having a deeper understanding of patients’ journeys and their pain points, while involving them in solution design will lead to greater compliance and engagement. The following exhibit highlights the various tenets of a patient-first solution.

Exhibit 1: Tenets of a patient-first design approach

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Six aspects of a patient-first design approach

  • Empathetic: DCT solutions should portray a deep understanding of the needs, well-being, and interests of patients, fostering trust and emotional connection. Vendors need to map the entire trial journey and look at it more holistically rather than logistically. Incorporating patient feedback into designing solutions will reduce a lot of stress and burden on patients
  • Secured: Concerns with data security, compliance, and privacy have increased with the rise in DCT adoption. Patients fear the consequences of device and network hacking, data leaks, and unauthorized access to data. DCT vendors must incorporate stringent security and compliance measures, secure the networks, and prevent all types of unauthorized access. With precise security measures in place, patients will feel safer with their data and will be more willing to share data for clinical research
  • Adaptable: DCT solutions must be able to incorporate the changing patient context, needs, and preferences to build fluid experiences. The same solutions should be adaptable and scalable as per the study requirement, ensuring a consistent patient experience and providing long-term sustainability
  • Engaging: Delivering engaging content is the best way to keep patients motivated in this digital world. Interactive educational materials, timely communication of trial progress (lay summaries), and patient reports go a long way in increasing patient engagement and retention. Patients can be motivated by increasing their trial literacy, setting up patient advocacy boards, and rewarding them for their contributions to the trial
  • Personalized: A one-size-fits-all solution will not work as patient experience varies at each stage and with each individual. Individualized care and personalized solutions help in building trust, loyalty, and retention rates among patients. Giving patients the liberty to choose their treatment plans (wherever possible), creating patient-specific digital ads, and supporting patients via artificial intelligence (AI) assistants are some of the ways to incorporate personalization into clinical trials
  • Reciprocity: Patients, vendors, and enterprises should be encouraged to communicate and share relevant experiences. Beyond trial periods, vendors and enterprises can engage patients with information on lifestyle, new developments on drugs or medical devices, upcoming trials, diet plans, etc. This type of communication will increase the willingness among patients to share personal data with AI systems as well as the scope with vendors, leading to more customized solutions that promote relevant and progressive experiences

Patients do not want to be treated as mere statistics. They want the touch of empathy and personalization, pushing DCT vendors to think more ‘humanly’ and add ‘emotional’ content while designing DCT solutions.

When all the above elements are incorporated in building DCT solutions, it will not only increase participation and adherence but also improve the brand value and bottom line for DCT vendors.

Over and above the empathy-backed approach toward creating a patient-centric solution, DCT vendors and enterprise buyers can look further at certain initiatives aimed at improving patient experience.

A sheer lack of awareness among patients regarding ongoing or planned trials exists. Enterprise buyers and vendors should spread information about upcoming clinical trials and steps to participate in them while promoting the ease of using digital technologies (via social media, newsroom, public releases, etc.). Home-care nurses or physicians still must make monthly calls or visits to motivate patients and add some scope for face-to-face interactions between patients and healthcare professionals.

Though the pivot or the integral enabler for DCT solutions is technology and connected systems, the focus should be on improving the patient experience and building the future towards a patient-intuitive smart DCT solution suite.

What are your views on how businesses can improve the patient experience? Reach out to [email protected] and [email protected] to discuss further.

Interoperability in Healthcare – Key Regulatory Implications and Beyond (Part 2) | Blog

The CMS Interoperability and Patient Access final rule has enabled key healthcare stakeholders – payers, providers, and health IT vendors – to realign their strategic goals and work toward enhancing member engagement and care delivery.

While interoperability in healthcare can deliver numerous benefits, complying with the rules can be complex and we are closely tracking this issue. In our earlier blog, we covered the evolution of interoperability over the years, the interoperability rule, and the challenges enterprises face in deciphering this regulation.

Read on for part two in our blog series that focuses on the data sets that need to be shared, steps involved in the data sourcing process, and the areas enterprises must focus on to navigate through the interoperability rule.

Which data gets shared as part of the interoperability rule, and what is the data sourcing process?

The interoperability rule has mandated payers to share across member- and plan-level information with the help of two Application Programming Interfaces (APIs) – patient access and provider directory. The rule also clearly identifies distinct data sets that need to be shared through both the APIs, as illustrated below.

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Having discovered what data needs to be shared, the next big question for enterprises is understanding how to extract this data. To make the necessary data available to its members through open APIs, enterprises primarily have to perform these three key steps: source system identification, data mapping, and data transformation.

  • Source system identification: As healthcare organizations store member information across multiple systems such as claims management system, Electronic Health Records (EHRs), etc., the primary objective is to identify the right source systems that house the information needed to be shared through the APIs
  • Data mapping: Data elements mandated by CMS are populated across various Fast Healthcare Interoperability Resources (FHIR) profiles such as patient profile, practitioner profile, etc. These data elements must be mapped against the respective source systems by matching the fields from the source database to the target database
  • Data transformation: FHIR profiles consist of data elements with attributes such as cardinality, data type, and binding value sets. The mapped data will have to be transformed into the FHIR recommended format by adhering to the data attributes (for example, translation of system codes into industry-specific codes, usage of industry- standard unique identifiers such as National Provider Identifier (NPI), Clinical Laboratory Improvement Amendments (CLIA) number, etc.)

 How do enterprises navigate through the CMS interoperability rule?

Although the interoperability rule defines IT investments payers, providers, and Health Information Technology (HIT) vendors must make, enterprises also need to plan for other critical aspects such as infrastructure scalability and data security in parallel. These areas will be crucial given the increasing data volume and demand for more streamlined services around data access and utilization.

The exhibit below illustrates the key IT remodeling themes and corresponding transformation levers for interoperability implementation in a healthcare enterprise.

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FHIR-based API ecosystem

The interoperability rule states that healthcare enterprises should establish API interfaces for all systems handling member/patient data and that the data transferred among healthcare entities – including the member/patient – should be in a standardized format. A robust API-led interoperability strategy can help healthcare enterprises curb the data liquidity issue within their ecosystems. The FHIR-based APIs will enable data format standardization between different endpoints, decrease development time, and save storage space on endpoint devices.

But just creating and establishing FHIR-based APIs will not suffice. Enterprises need to integrate and orchestrate formats other than FHIR. While connectivity with standard or off-the-shelf systems will be easier, homegrown/custom systems will be challenging to map to FHIR standards. In-house development teams and technology vendors will have to create workarounds to modify existing components that consider the potential variability in medical terminologies.

Infrastructure layer

With the implementation of FHIR-based APIs, enterprises must assess scalability challenges within their existing infrastructures. To accommodate the upcoming member/patient data access requests and enable quick data retrieval, enterprises should start to manage their current data storage and compute capacities. Enterprises can approach the data scalability and infrastructure issue by either leveraging existing infrastructure to build an FHIR-based layer or partner with technology vendors to leverage their data, cloud, or FHIR platforms.

Security layer

As healthcare enterprises will have access to multiple data sources, healthcare interoperability might open the door to security breaches and cybersecurity threats that may not have existed if the data resided within the enterprise. With the influx of data from other healthcare entities, current standard security checks might not be able to cross-reference and validate the identity of the entity requesting access, creating openings for data breaches. To manage these security challenges, added investment in particular focus areas (e.g., application penetration testing, consent management, member education) can help enterprises achieve sustainable data security.

The road ahead

While enterprises are complying with the CMS mandate, an increased focus must be put on how they can look beyond regulations to address some of the key pain points in the industry, such as patient experience, care management and outcomes, and total cost of care. With data flowing seamlessly across the healthcare ecosystem, enterprises should identify and invest in areas that would be crucial to creating long-term business value while also giving them a competitive edge.

As part of our third blog in this series, we will next cover how healthcare enterprises can approach the interoperability rule beyond the mandate to reap long-term benefits, key investment areas, value for enterprises, and an interoperability enablement framework that provides a view into the required IT components for regulatory compliance and what goes beyond regulation.

Please feel free to reach out to [email protected] to share your experience and ask questions.

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:

Picture 2

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].

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