NCCN Recommends NGS in All Stages of Pancreatic Cancer: Direct Conflict with Outdated Medicare NCD

Tuesday, I was in a webinar where stakeholders were discussing the badly-outdated Medicare NCD for NGS testing in cancer.  Thursday of the same week, more proof of the problem hit my inbox.

See the March 18, 2026, release of new pancreatic cancer management guidelines from the National Cancer Center Network - NCCN.   Here.   See coverage in Genomeweb, here.

NCCN is the gold standard in cancer care guidelines.  They've updated genomic testing guidance for pancreatic cancer management.   Here's the redline:

Here's the new active text, from page 10, "Clinical Presentation and Workup."  The same NGS recommendations occur on other pages for other stages or scenarios.

Tumor/somatic molecular profiling, preferably using a next-generation sequencing (NGS) assay, is recommended for all patients who are candidates for anti-cancer therapy to identify clinically actionable and/or emerging alterations.

These alterations include, but are not limited to:

• fusions (ALK, NRG1, NTRK, ROS1, FGFR2, and RET),

• mutations (BRAF, BRCA1/2, KRAS, and PALB2),

• amplifications (HER2),

• microsatellite instability (MSI),

• mismatch repair deficiency (dMMR), or

• tumor mutational burden (TMB)

using comprehensive genomic profiling via an FDA-approved and/or validated NGS-based assay, and HER2 overexpression via immunohistochemistry (IHC) ± fluorescence in situ hybridization (FISH).

In addition to DNA sequencing, RNA sequencing is recommended since it is better at detecting gene fusions.

Testing on tumor tissue is preferred; however, circulating tumor DNA (ctDNA) testing can be considered if tumor tissue testing is not feasible.

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The current National Coverage Decision, written nearly ten years ago, allows NGS management of cancer only for relapsed or advanced Stage III, Stage IV, disease.    Clearly, NGS is necessary at earlier stages, as NCCN shows here, as well as some neoadjuvant/adjuvant decisions, which may often involve Stage 2 patients.

So it's one more argument that the CMS NCD - which dates from the first Trump administration in 2017/2018 - needs to be updated.  

The NGS NCD, one of the first uses of Parallel Review, was a groundbreaking and innovative approach then - under administrator Seema Verma and Health Secretary  Azar.   

Now, nearly ten years later, under leadership like Secretary Kennedy, senior advisor Chris Klomp, Chief Medical Officer Dr Dora Hughes, and CMS administrator Dr. Oz, it's time to move the clock forward again.  We must keep this NCD up to date for Medicare patients with cancer.  we should fix it now.

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(Klomp is currently Director of Medicare and Deputy Administrator of CMS, and Senior Advisor to HHS Secretary Kennedy.)