Balancing national guidelines with condition-specific criteria leads to improved payer policies and better health outcomes for patients

A hallmark of InformedDNA’s approach to improving patient care while better managing healthcare costs is the unique breadth and rigor of our clinical guidelines for appropriate use of genetic tests. Unlike other genetic test clinical appropriateness criteria, which typically include criteria at the test or CPT code level only, ours follow an intended use or condition-specific model.

Why a condition-specific approach?

With more than 75,000 genetic tests available today and an estimated 14 new testing products entering the market every day, it’s difficult for stakeholders across the healthcare system to keep pace with change. Our approach organizes criteria by clinical condition, enabling us to address 100 percent of available genetic tests by focusing on the relatively smaller number of conditions for which genetic testing is beneficial.

Determining clinical appropriateness is complex because genetic testing incorporates unique variables such as gene, testing method and lab. In addition to evaluating the medical necessity of testing for the indication, the test itself must also be evaluated for appropriateness. A condition-specific approach supports providers, too, who commonly say they do not know which tests to order or how to interpret the results. Our criteria follows clinical logic, addressing each condition and pointing to the needed test or tests.

Why is policy-writing for genetics different than for other specialties?

There are many reasons policy-writing for genetics is different than for other specialties. Genetic testing spans all medical specialties and disciplines, with wide variability in test indication, from diagnosis, to medication choice and dosage, to reproductive planning, to chemotherapy, to risk assessment. Additionally, tests may appear similar but employ vastly different technologies, calling for highly skilled assessment and interpretation.

The InformedDNA approach to clinical guidelines regarding genetic tests is distinctive. Our condition-specific model takes national guidelines into account. But, because we have the largest full-time staff of lab-independent genetic specialists in the nation, we are also able to perform independent evidence reviews of clinical utility. The clinical experience and deep subject-matter expertise of our team means we have a clear understanding of the challenges associated with using genetics in healthcare — and the most appropriate, safe, effective solutions.

Through our strong partnership with AIM Specialty Health®, we lessen prior authorization complexities. Using the Clinical Appropriateness Guidelines for Genetic Testing, developed through our rigorous process that integrates evidence-based literature review with clinical expertise, we provide a fully automated genetic test prior authorization service. When manual review is needed, our genetic analysts use case-specific information and evidence-based criteria to make recommendations. We can also readily avoid unnecessary denials by guiding providers to alternative tests and labs when appropriate.

Many payers struggle with coverage decisions for tests that come to market with sparse or weak published evidence of clinical utility. Our coverage determination framework allows for consideration of a diverse set of important drivers, such as benefit to additional family members, cost effectiveness, alternate testing strategies, and risk of harm to patients. This comprehensive approach guides informed coverage decisions for tests that are heavily marketed or that have FDA or CMS approval with little supportive evidence.

InformedDNA's Genetic Benefits Management Solutions

At InformedDNA, we are obsessed with the field of genetics. Our “full-cycle” Genetic Benefits Management™ solution considers the genetic test life cycle and takes into account the needs of all stakeholders: Patients, providers, labs, health plans and patients.

  • Ordering providers have ready access to automated prior authorization and direct access to genetics expertise, while enforcing evidence-based test choices.
  • Patients receive telehealth genetic counseling that leads to informed testing and treatment decisions.
  • Health plans realize up to a 40 percent reduction in genetic testing costs through elimination of inappropriate testing and billing.

Our mission is clear: We optimize genetics-related patient care and healthcare spending by improving access to clinical and scientific genomics expertise. By integrating national guidelines with condition-specific criteria, our clinical guidelines lead to optimal use of genetic testing that benefits everyone we serve.

Have questions or want to chat about InformedDNA’s services? Simply fill out the form below and we’ll get back to you quickly, or give us at 844-846-3763.


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