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  1. 1. 22 by Franziska Moeckel, MBA Consumer-Directed products, in the context of this article, are services that may or may not be marketed directly to consumers and can be purchased directly by the individual but that require a healthcare professional to order the test or test bundle. Some recent examples include Color Genomics – a company that offers affordable genetic testing, including BRCA1 and BRCA2, to help understand genetic risk for breast and ovarian cancer; Arivale – a business dedicated to providing individuals a scientific path to wellness; the Health Nucleus – a wholly owned subsidiary of Human Longevity Inc. that is the first-of-its-kind genomic enhanced, research based health platform; Veritas Genetics – “the first company in medical history to offer individuals the opportunity to easily and affordably unlock the secrets of their entire genome.” While Color Genomics focuses on making genetic testing accessible and “allow[ing] people to catch cancer at an earlier and more treatable stage or prevent it altogether,” Arivale focuses on wellness “by leveraging an individual’s unique genetic makeup, clinical lab data and lifestyle to optimize wellness and avoid disease.” The Health Nucleus, also concentrating on wellness, “uses whole genome sequence analysis, advanced clinical imaging and innovative machine learning – combined with a comprehensive curation of personal health history – to deliver the most complete picture of individual health.” In comparison, Veritas Genetics promises that “you can sequence your entire genome and gain a completely new understanding of what’s possible when it comes to using your genetic information together with your doctor to improve your health and longevity.” There are many other choices. Healthcare providers – independent practitioners, physician groups, and health systems alike, are increasingly confronted with DTC and CD products as part of their day-to-day practice, a trend that is anticipated to only grow in the future as the sophistication and curiosity of empowered, educated individuals regarding their genetic makeup (and other organisms living within the human body) matures. W ith more and more Direct-to-Consumer (DTC) and Consumer-Directed (CD) ‘Omics products hitting the US market, leading providers, physician groups and healthcare systems in the field of personalized or precision medicine have a decision to make. Should they be active participants in the Consumer-Directed and/or Direct-to-Consumer movement; should they invest in alternative offerings; or should they even separate themselves from such products completely? Experts in the field define Direct-to- Consumer (genetic) testing as testing sold directly to consumers via various marketing channels, including TV, the internet, social media platforms or other marketing venues without involving a healthcare professional or insurance company. Companies such as 23andMe – a leading personal genetics company with the goal to help people access, understand and benefit from the human genome, and uBiome – a citizen science project that allows the public access to cutting edge sequencing technology to understand their microbiome, are just two prevalent examples for DTC testing. While 23andMe markets itself as the “first and only genetic service available directly to you that includes reports that meet FDA standards” and includes reports on carrier status, ancestry, wellness, and personal traits, uBiome, on the other hand, allows an individual to “explore your microbiome” by extracting bacterial DNA out of an individual’s sample.
  2. 2. 23 COGNOSCIENTI People who have participated in one of the DTC testing services approach their primary care physician (or specialist) and present their results with the expectation that the information is either understood by their doctor or that this information should be part of the treatment pathway and medical record moving forward. Regardless of what the situation may be, providers have a choice to make: to either participate and partner with patients and these companies, to build their own version of DTC and CD offerings, or to ignore this trend altogether. They can choose to lead the movement, follow the leader, or watch from the sidelines (Figure 1). Yet, there is no black-and-white answer to this question. When taking an active approach to this overarching strategic issue, assessing whether or not a product is worth the investment by evaluating many competing elements before making a business decision is crucial. The framework below can assist in making these decisions. l Legal: Reviewing company policies and compliance with the Food and Drug Administration (FDA) regulations if applicable – especially for DTC services. l Media: Researching paid and earned media content. Is the tone positive, neutral, or negative? l Marketing: Estimating the company’s marketing engine and strength in conjunction with the associated brand awareness and value in your market. l Core Competencies: Understanding the company’s core competencies in comparison to your own, e.g. clinical testing quality, report information comprehension levels, customer service, etc. Product Overview and Fact Gathering To understand which product(s) and service(s) the company is offering and associated customer group(s). This step includes: l Test Benefits & Target Market: Summarizing product offerings and benefits for each target customer group – especially the individual; assessing user interfaces based on user- friendliness and a certain “fun” factor. l Cost Structure: Listing test costs as part of the service package, incl. individual and bundle test costs, discounts, membership models, affiliation programs, premium versus standard services etc. l Technical Test Specifications: Reviewing the list of genes (or other test specifications), laboratory environment (can be multiple laboratories at different locations) where each of the tests is performed (internal/external laboratory, Clinical Laboratory Improvement Amendments (CLIA) / College of American Pathologists (CAP) certified / research setting), technology used (platform(s)/machine(s)), depth of coverage (for whole genome and whole exome sequencing) and associated test report details. l Customer Service: Understanding customer service standards and access points (phone, email, chat) for both the individual and the physician. Figure 1. Precision Medicine Implementation Lifecycle Introduction & Education Limited Acceptance Low Utility High Cost No Reimbursement Utility Time Awareness & Undestanding Growing Acceptance Increasing Utility High Cost Limited Reimbursement Awareness & Adaptation High Acceptance Constant Utility Reduced Cost Wide Reimbursement Awareness & Abandonment Diminished Acceptance Decreased Utility Constant Cost Wide Reimbursement Innovators Early Adaptors Majority Laggards First Mover Threshold Organizational Fit To determine organizational fit between your entity and that of the company providing DTC or CD services – it encompasses how the company aligns with your mission, vision, business objectives, and overall strategy. This step includes: l Company Profile: Assembling a company profile, incl. the type of entity you are evaluating (for-profit vs. not-for-profit, mission/vision, core values, etc.) and how it compares to your purpose. l Leadership: Reviewing the leadership team, incl. the medical and research team, board of directors, and advisory board (balance between scientific, clinical, and business experts is important), as well as the number of staff employed, etc. l Investments: Profiling the company’s investors (if any) and the type of investments made, incl. the amount and type. This history is also crucial for assessing investment potential (if applicable).
  3. 3. A B 24 Figure 2. Direct-to-Consumer and Consumer-Directed Product Assessment Framework Categories Objectives Assessment Components • Company Profile / Core Values • Leadership Team • Investments • Legal/Government Regulations • Media Coverage • Marketing Plan • Company Core Competencies • Test Benefits & Target Markets • Cost and Pricing Structure • Technical Test Specifications • Customer Service • Company Fact Sheets • Current Customers • Data Sharing Models • Report Templates & Integration • Support Services • Competition • Research Projects • Test Panel Composition • Clinical Validity and Patient Benefits • Research Application • Physician Interaction • Quality Controls • Partnership Model • Staffing Requirements • Buy versus Make Decisions • Electronic Health Record (EHR) Integration • Payment Terms • Education & Training • Product Modification / Enhancements l Fact Sheets: Reviewing company fact sheets (scientific and non-scientific). l Customers: Researching company partners and current customers. l Data Sharing: Investigating data sharing principles with the individual and physician and in which format, incl. information shared with individuals as part of coaching process. l Reports: Reviewing report templates and content, including support tools for both the individual and physician, as well as interpretation benchmarks. l Support Programs: Evaluating existing health coach or genetic counselor programs and format thereof (face-to-face, group setting, phone, email, video conference, etc.) l Competition: Comparing product(s) to other similar internal and or external products available, incl. cost, list of genes and associated reports, customer support services, etc. l Research: Understanding whether or not the data generated is used for research. Clinical Validity and Physician Uptake To clarify whether or not the product or service has clinical validity (is evidence-based) and to gauge physician acceptance. This step includes: l Test Panel Composition: Analyzing test details, tests included and not included in an assay and reasons for doing so. l Clinical Validity: Establishing if test(s) are based on evidence and have clinical validity that can be supported by peer-reviewed research studies, research data, publications, etc., as well as assessing which patient/ consumer benefits are derived from offering the test(s). l Research: Determining whether or not data is used for the company’s research endeavors, and, if so, whether or not the study has undergone International Review Board (IRB) approval, incl. informed consent forms used, research goals established, etc. l Physician Interaction: Setting expectations for physician interactions and requirements, such as test ordering and report returns, as well Organizational Fit To determine organizational fit between your entity and that of the company providing DTC or CD service – it encompasses how the company aligns with your mission, vision, business objectives, and overall strategy. Product Overview To understand which and Fact Gathering product(s) and service(s) the company is offering and associated customer group(s). Clinical Validity and To clarify whether or not the Physician Uptake product or service has clinical validity (evidence-based) and to gauge physician acceptance, and benefits to patient care. Business Approach To define the business model most appropriate for your provider(s). as addressing how the use of the test will add or reduce time spent on clinical workflows. l Quality Controls: Agreeing on what quality controls must be in place at both institutions.
  4. 4. 25 COGNOSCIENTI Business Approach To define the business model most appropriate for your provider(s). This step includes: l Partnership Model: Negotiating partnership details such as a pilot project and beta sites, patient benefits for participation, cost and profit sharing terms, volume discounts and requirements, additional services provided as part of the partnership agreement, distribution channels (concierge medicine, employees, insurance plan participants, all patients, etc.) l Staffing: Understanding any additional internal staffing requirements if any. l Buy versus Make: Agreeing on which laboratories will be used for which test (internal/external) and environment (research versus CLIA/CAP certified) and understanding the impact on market share if any. l Electronic Health Record (EHR) Integration: Defining whether or not the platform used by the company is compatible with your Information Technology infrastructure and whether or not one- or bi-directional data sharing is permitted. l Payment Terms*: Determining who pays for test offering and through which channel – your entity, the company (as a pilot project), the individual, or the insurance plan*. l Education & Training: Agreeing on which entity is responsible for consumer education and physician training. This includes an evidence-based library, marketing materials, and type of education channels (print, video, etc.) l Product Modification / Enhancements: Evaluating if product modifications or enhancements are beneficial to the new offering, e.g., your own organization’s (add-on) services. l Data Storage and Management: Facilitating an agreement making determinations about data sharing, research use of data and by which parties, specific data access points, and the responsible party for data storage and management. l Intellectual Property: Understanding who owns the rights (if not shared) to intellectual property created as part of the business deal. Workflow Integration To determine how the new test or offering will be integrated into any existing internal processes and workflows. This step includes: l Information Technology: Identifying any requirements for technology integration and interoperability, such as with an EHR, third party billing system, laboratory reporting platform, as well as data sharing structures, ICD-10 medical necessity coding requirements for reimbursement (if any) and the location and management of these systems. l Legal and Compliance: Following internal, state, and federal regulations specific to your company, as well as assessing other existing partnership agreements and contingencies. l Managed Care Contracting*: Understanding any impact on existing managed care contracts for medically indicated testing services similar to the product being assessed. l Marketing / Communications: Facilitating an integrated marketing and communications plan if needed. l Pricing (Charge Master): Determining a price for a product that has either been modified, enhanced, or will be promoted and sold directly by your entity. l Laboratory Interface: Facilitating the integration of internal laboratory services into the new process, such as phlebotomy, courier services, etc. Franziska Moeckel, MBA. Franziska Moeckel is the Assistant Vice President, Personalized Health at Inova. In her role, Franziska is leading business operations and product launch activities for molecular diagnostic testing as part of an in-house, CLIA-certified genomics laboratory, and is assessing and promoting new ‘omics features for clinical practice, including consumer-directed and direct-to-consumer products and services. As part of the new Inova Center for Personalized Health team, she is providing strategic direction and thought leadership around the integration of precision medicine and individualized wellness. “ Regardless of what the situation may be, providers have a choice to make: to either participate and partner with patients and these companies, to build their own version of DTC and CD offerings, or to ignore this trend altogether.” These steps are suggestions and may or may not apply to your organization as DTC and CD products evaluated may differ and as company goals, management structure, as well as overall sophistication levels and technological integration requirements vary from entity to entity. *Generally, Managed Care Contracts and insurance plans currently do not cover or reimburse for Direct-to-Consumer (DTC) or Consumer-Directed (CD) tests due to the lack of medical necessity. However, a forward looking approach has been taken in this assessment and for this framework.