BLOODPAC Summit 2022

Ten Years of Progress in Five

BLOODPAC was launched as a commitment to the White House Cancer Moonshot to accelerate the development, validation, and clinical use of liquid biopsy assays to better inform medical decisions and ultimately improve patient care and outcomes.

Five years later, members of the BLOODPAC Consortium came together to reflect on the journey and discuss the goals we’ve set for our next chapter.

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Q&A

Our audience had so many questions for us during the Summit, we couldn't get to them all. Below you will find answers from our Consortium members to some unanswered questions.

  • We were pleased to see that National Government Services finalized its plans to cover comprehensive genomic profiling (CGP), on April 1st, to aid late-stage patients and their care teams with essential therapy selection information. This policy (L37810) introduces CGP to Medicare beneficiaries in 10 states. However, it only includes tissue-based Next Generation Sequencing testing…and excludes ctDNA assays.

    The Reimbursement Work Group made a public comment on November 11th and this glaring absence was noted as our first of four requests. While the comment period has ended and the local coverage determination (LCD) is final, please direct opinions to NGS via email at PartBLCDComments@anthem.com

    —Rob Dumanois, Director of Reimbursement Strategy, Clinical Sequencing Division Thermo Fisher Scientific

  • Patients have an increasing number of options for tests to determine actionable genetic variants or genome-wide signatures in order to guide therapy so they can benefit from more personalized treatment. Tissue-based analysis and liquid biopsies for treatment selection complement each other and, as you suggest above, can be used together for some patients in order to ensure they have the best chance of finding life-changing therapy. At this time, it is premature for BLOODPAC to recommend any specific sequencing of tests, and a patient’s care team is best positioned to determine what tissue is available and recommend the best path forward. However, as the field matures, we do anticipate BLOODPAC working to help establish and advocate for best practices when using liquid biopsies for cancer patients.

    —Phillip G. Febbo, MD, Chief Medical Officer, Illumina

  • As you point out, coverage for LBx and CDx varies widely by payors. One avenue to remove this coverage bottleneck is through state legislation. Several states have passed or are considering such legislation now. Illinois and Louisiana expanded coverage last year and Arizona followed suit in May 2022. Similar legislation is also now under consideration in California, Ohio, New York, Minnesota, and Rhode Island. These bills would mandate that private plans and Medicaid cover biomarker testing that is supported by scientific evidence, such as FDA labeled indications, a CMS national or local coverage determination, or clinical practice guidelines.

    —Emma B. Alme, PhD, Director of Public Policy, Guardant