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The final decision includes some changes, most notably removing requirements for guideline inclusion, but retains its technical performance benchmarks.
Myriad Genetics' EndoPredict, Agendia's MammaPrint (distributed in Germany by PathoNext), and Veracyte's Prosigna will now be covered by public insurance.
The final national coverage decision stipulates that NGS germline tests for assessing hereditary breast and ovarian cancer risk must have FDA's blessing.
The government payor asked the public to specifically weigh in on the evidence supporting germline testing to assess treatment benefit for patients with hereditary cancer syndromes.
CMS had received significant stakeholder feedback that germline NGS testing is not the same as somatic testing, and that the NCD as written would negatively impact patients.
The agency said it is sensitive to stakeholder concerns and is working with MACs to adjust claims processing systems.
An Oregon Health Authority committee issued a draft guidance to not cover NGS testing for solid tumors, which advocacy groups say will limit access to Medicaid beneficiaries.
A private payor survey by ClearView Healthcare Partners found that medical directors viewed CMS's decision with caution; half had no plans to align commercial plan coverage.
A perspective that hasn't gotten as much attention is that the CMS draft coverage decision could be bad for patients by increasing off-label drug use based on the results of NGS panels.
Some industry players are accusing CMS of advancing backdoor LDT regulation by proposing to cover NGS tests with FDA approval/clearance, except in a limited setting.