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May 30, 2019

Emergence of Hybrid Models of Genetic Testing Beyond Direct-to-Consumer or Traditional Labs

Author Affiliations
  • 1Center for Translational and Policy Research on Personalized Medicine, Department of Clinical Pharmacy, University of California, San Francisco
  • 2Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco
  • 3Center for Business Models in Healthcare, Chicago, Illinois
JAMA. 2019;321(24):2403-2404. doi:10.1001/jama.2019.5670

Historically, genetic evaluation has been dominated by a clinician-centric traditional model in which a patient’s physician had the central responsibility for testing, such as ordering the test and communicating the results. Conversely, in the direct-to-consumer (DTC) model, consumers are more empowered because they can order their own tests, obtain samples using home test kits, and receive the results directly from the laboratory or company that provides the test. The DTC market has expanded substantially, reigniting controversies over the potential implications of DTC testing for genetic health risks.1

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    2 Comments for this article
    Need for Payor-Oriented Translational Research
    Richard Nicholas, MBA, Duke University | TPA Network Research Consortium
    Thank you for conducting this study as there is an urgent need for research on how to translate genetic and genomic testing to better inform patients, their physicians, employers and, most importantly, payors. The hybrid testing model that you discuss is indeed catching on as the overabundance of labs desperately try to find a way to tap into both the consumer and payor markets.

    As I see it, the issue at hand is how to get the payors interest in reimbursing for genetic and genomic testing…as until they do, the industry will be at a
    stall. I have been in the healthcare field for more than four decades and I have learned many things over that time, including this: follow the money. Genetic testing will not go anywhere without the payors getting onboard to cover it. Until there are pragmatic translational research studies aimed at measuring and proving efficacy, cost-effectiveness and (now) value, there is going to be tension between patients and physicians who recognize the value of precision medicine vs payors who have not yet embraced it as there are virtually no studies that address their concerns. There is simply no good reason for that.

    Health insurance companies and managed care organizations have been historically slow to act as it relates to uptaking emerging medical technologies, health innovations and new ways of doing business. They are large, bureaucratic organizations often headed by people who want new advances to go away while on their watch. Their Pharmaceutical, Therapeutics and Medical Technology Assessment Committees are expert at hiding behind the term “experimental” whenever they can get away with it. Tha said, there needs to be more independent research conducted with them in mind and focused on return-on-investment, improved clinical outcomes and value (vs. the standard of care). Indeed, over the past fifty years it has not been the large insurers and MCOs that have encouraged innovation in health plan design and administration; it has been the self-funded segment of the market headed by small third party administrators (TPAs), and for good reason. Their clients are typically more plan participant-centric, more aggressive about managing cost and utilization and, therefore, early adopters and adapters. The TPAs that manage their plans are much more progressive and nimble as it relates to accepting and implementing change and they are very good at doing one thing well: they do what their clients want.

    Unfortunately, being a fragmented market, TPAs do not have the wherewithal to have a professional committee as described above funded with millions of dollars. That is why I established the TPA Network Research Consortium: to be that committee for the self-funded industry. Our real world evidenced-based pragmatic translational research studies will focus on topics of interest and import to this market (which encompasses tens of millions of people) and all Americans. Our research will be conducted by independent scientists, researchers and medical professionals from the nation’s leading universities and research facilities. As important, we will focus on issues of interest to payors, because we know that until they get on board with paying for new innovations, those like genetic and genomic testing will not go anywhere and will remain where it is today: with fewer than 10% of the testing claims submitted being reimbursed. And, because we know that genetics and genomics will change how medicine is practiced, our first study is on "genetic benefits risk management".
    CONFLICT OF INTEREST: I operate the TPA Network Research Consortium, a B-Certification seeking organization designed to accelerate the evaluation, adoption and assessment of new medical technologies and healthcare innovations and provide guidance on their adoption and implementation by payors
    Accelerating the Widespread Adoption of Efficacious Genetic Testing to Reduce Risk and Improve Outcomes
    Jacqueline Easley |
    Your study was of great interest to me because over the past many months we have seen a great number of genetic/genomic laboratories expand their business model to include a variety of hybrid approaches to dealing with patients and their physicians in an effort to increase volume and reimbursement by payors from the current dismal state. As you rightly point out, one issue at hand is which of these approaches is “the best” and are any doing harm?

    These are exactly the questions we intend on researching, evaluating, assessing and providing guidance on from a
    payor perspective. Accordingly, we have been working closely with academic researchers from the nation’s leading universities and research institutions; all of the leading genetics/genomics laboratories; DNA test translation service companies and technology vendors; genetic/genomic medicine practices; PharmD networks; and world-wide exchanges able to blockchain secure store, share (with researchers) and monetize DNA/test results on behalf of patients. Every one of them has agreed to participate in our research study which will focus, in part, on how each of these components works best within the genetics/genomics ecosystem, exactly the topic of your article.

    By example, we will study, evaluate, assess, compare and contrast the (outcomes, behavioral and cost) effectiveness of how genetic counselors interpret and deliver pharmacogenetic test results versus a pharmacogenetic-trained pharmacist from the patient’s, prescribing physician’s, and payor’s perspective.

    To the best of my knowledge, this research does not presently exist and will be of enormous value to both self-funded employers, TPAs, health insurers and managed care organizations alike and help to do what all of us that understand and appreciate the promise of precision medicine want: the accelerated widespread use of this game-changing scientific advancement in an efficacious, cost-effective, value-oriented and regulatory compliant way.
    CONFLICT OF INTEREST: The Genetic Benefits Consulting Group (a B-certification seeking transparent organization) has been commissioned by the TPA Network Research Consortium to conduct what we believe to be the largest real-world evidence-based pragmatic translational research study performed in the genetics/genomic field having a focus on the interests of payors. This study will involve the genetic/genomic testing of more than 100,000 participants of self-funded health plans administered by the nation’s leading third party administrators.