This session will review at least one case study, involving implementation across several healthcare ecosystem stakeholders (payer, provider, industry), aimed at addressing various issues associated with the commercial clinical adoption of exome and genome sequencing in pediatric rare disease.

Many of us worry about how to prepare for the inevitable Zombie Apocalypse.  At least we can glean information from The Walking Dead and Zombieland to better prepare us for that day.  But what guidance do we have to prepare us for discussions with payers about test coverage? No movies, TV shows or books are available to help us with that.  But that's all about to change. This presentation was designed to explain how payers think about test coverage and what they want from you. Trust me, giving them your "evidence" is much easier than parting with your brain.   

The process by which CMS establishes reimbursement rates for new codes appearing on the Medicare Clinical Laboratory Fee Schedule can be opaque and unpredictable, resulting in significant uncertainty for novel technologies entering the market. This presentation will discuss the crosswalk and gap-fill processes, their impact on private payers and PAMA implementation, and potential policy solutions to improve them.

• Value creation tools/processes
• Considerations for a compelling value proposition
• Considerations for maximizing value​

2024 is a busy year at CMS. New approaches to coverage are proposed (Transitional Coverage for Emerging Technologies). New rules are being tested to improve the sometimes nightmarish swamp of getting Medicare Advantage coverage and payments. Stakeholders continue to debate the dysfunctional 14-day rule that delays critical genomic tests for cancer patients. CMS struggles to handle AI testing ("indirect IDTFs" vs. procedure "bundling"). MolDx takes new policy positions, such as how it handles advanced proteomic tests for cancer, and brings out a flurry of new LCDs.  We'll update on all this and more.

This talk will review the concepts and processes for molecular diagnostics payor controls. The discussion will include a description of 1) differentiating Medicare and private payors; 2) the difficulties of claims processing in molecular diagnostics; 3) DEX registry; 4) technical assessments; 5) how to approach Medicare for reimbursement; 6) policy-writing procedures for Medicare; 7) how payors consider evidence.

Join John Warren as he shares his firsthand experience organizing and managing a recent pre-submission meeting with the MolDX program. Learn what worked for his client and hear what he would do differently the next time around.

Despite the election year polarization, Congress is taking action that impacts laboratory test reimbursement —from conducting oversight into Medicare Advantage and Managed Care Organizations to introducing legislation to reform prior authorization, enhance transparency in pricing, and increase coverage for certain innovative tests. This presentation will explore trends in Congress’ approach to resolving barriers to reimbursement, as well as provide insights into what legislation is likely to advance and successful strategies for engaging policymakers to increase support for continued innovation in diagnostics.

Biomarker testing is revolutionizing the treatment of cancer and other conditions but these advances are not benefiting all patients equally. Insurance coverage for biomarker testing is not keeping pace with the science, contributing to disparities in which patients can get the testing they need. ACS CAN and partners have worked to pass legislation in 16 states (and counting) to align coverage of biomarker testing with the latest evidence.

In recent years, state legislators have introduced dozens of measures requiring health insurers to cover a diverse array of biomarker tests. This surge in legislative activity reflects policymakers' commitment to enhancing access to biomarker testing. However, it also signifies a significant shift in market dynamics, presenting implementation challenges for affected stakeholders. Join us as we explore the evolving landscape of coverage and patient access within this dynamic field of medicine.

CPT codes to describe genomic tests have changed rapidly over the past few years. The CPT Editorial Panel, in response to consistent feedback to enhance the clarity of important areas of genomics, has created several workgroups to address these issues. Learn how over the past year several new coding paradigms have been approved by the CPT Panel to ameliorate issues in coding for genomic tests.

Proprietary Laboratory Analysis (PLA) codes, within the CPT codeset, began in 2018. These codes were driven by the Protecting Access to Medicare Act (PAMA) legislation requiring a coding solution to report clinical laboratory diagnostic tests with increased specificity, particularly for Advanced Diagnostic Laboratory Tests (ADLTs), but also for Clinical Diagnostic Laboratory Tests (CDLTs). This program discusses practical considerations when considering and requesting a PLA code for a unique test, the PLA application process, and then the subsequent issues for assuring appropriate reimbursement once a code is recognized.

ADLTs represent innovative tests that “provide new clinical diagnostic information that cannot be obtained from any other test or combination of tests.” Since ADLTs are the first tests to address unmet clinical needs, a core question is if the evidence shows that (a) clinicians change their treatment pathways and (b) that these changes improve outcomes and reduce overall healthcare costs. A case study will be presented.