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Achieving Success with Next-Generation Sequencing: AI-driven Scale Plus a Strong Reimbursement Strategy

XIFIN, Inc. and Fabric Genomics recently collaborated on a webinar designed for laboratories launching or planning to launch Next-Generation Sequencing (NGS) tests. The two primary topics of the webinar are:

  1. The use of artificial intelligence (AI) to drive scale with panel testing, including practical considerations for implementing NGS testing and selecting the right panels, and automating and scaling NGS testing through integrated clinical workflows
  2. The pathway to reimbursement

This discussion also included best practices and clinical services for labs launching or scaling genomic tests.

The NGS market is growing rapidly. Fortune Business Insights reported that the global market in 2018 was $6.36 billion, expected to grow to $31.4 billion by 2026. This represents a 22 percent cumulative aggregate growth rate (CAGR). The drivers for this growth include:

  • Increasing demand for drug discovery applications requiring NGS technology and diagnostic tests based on sequencing
  • Rapid pace of new test kits and services being introduced for non-invasive prenatal testing, cancer diagnosis, and other conditions
  • Improving governmental support for product approval and reimbursement coverage for NGS-based diagnostic tests
Watch the full webinar here

The expansion of NGS is driving costs down and making this testing more accessible to patients. However, this rapid growth comes along with some challenges for laboratories. First, reimbursement is ever more tied to clinical utility, which equates to a greater need for supporting documentation for claim submissions and appeals. Second, disparate systems make streamlined workflow difficult.

The presenters cover NGS testing reimbursement trends, with a particular focus on prior authorization, medical necessity, and clinical utility requirements. The two key components to reimbursement and getting paid are payor coverage and assignment coding. Coding is especially challenging because there are 75,000 tested conditions with a handful of approved CPT codes. It is common for NGS laboratories to see denial rates above 35 percent. The significant denial reasons include:

Experimental of Investigational

Medical Necessity

Prior Authorization Required

This creates a significant administrative burden for diagnostic providers and a delay of testing for patients. A high test abandonment rate often results from these delays.

There are eight keys to success related to reimbursement for NGS tests:

  1. Engage with the right level of decision-makers at the payor level
  2. Educate payors to expand access
  3. Leverage key opinion leaders
  4. Align with payors on evidence requirements, billing policies, and coding preferences
  5. Leverage claims to encourage payor policies
  6. Educate clinicians to ensure medical necessity and medical record documentation
  7. Collaborate with clinicians on the prior authorization process
  8. Educate patients

Next, the presenters discussed practical considerations for scalable NGS testing and informatics. First, there are lab system considerations for NGS, including the need for a flexible system, with open APIs that connect with instruments and integrate with the lab’s billing platform. Other practical considerations include:

  • Getting prepared for volume with plate mapping
  • Having integrated workflows that automate mapping of specimens
  • Understanding the value of AI-based approaches
  • Using panels to scale and generate revenue

The advantages of AI in NGS analysis include:

  • Automating the ACMG classification process to provide rapid results ready for the lab director
  • Synthesizing knowledge from disparate databases to achieve new clinical insights
  • Minimizing geneticist cognitive load by scaling expertise for higher throughput

As the number of valuable NGS tests continues to accelerate, it is imperative that laboratories are prepared for both the pathway to reimbursement and the use of AI to drive scale. There are now established use cases for the benefits of AI in interpreting NGS test findings. To learn more about the details of these recommendations, please watch the webinar, “Achieving Success with Next-Generation Sequencing: AI-Driven Scale and a Strong Reimbursement Strategy.”

Published by XIFIN
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