The agency has proposed rolling back exemptions gained in a 2018 revision of the rule that labs say are key to maintaining access to molecular testing.
The test, TruGraf, assesses differentially expressed genes in blood to rule out subclinical kidney transplant rejection in patients with stable renal function.
While industry organizations remain optimistic the bill will pass, others note challenges, including a lack of strong Congressional support and political gridlock.
According to industry groups, some vendors are reporting providers have returned POC testing systems because the economics of using them no longer makes sense.
The health technology firm is proposing a new software solution that would standardize coding in genetic testing, but a more predictable system would also narrow variability in test pricing.
In response to CMS reopening its national coverage determination to address its germline testing policy, stakeholders point out areas of concern and confusion.
The CMS ruling follows the release of data showing strong performance of the test, including its ability to detect bloodstream pathogens missed by blood culture.
As NGS testing becomes more widespread, labs, payors, and professional groups confront questions about which genes should be required as part of clinical assays.
The firm said that UHC will cover the test for patients with major depressive disorder or anxiety who have failed to respond to one or more treatments.
The bipartisan legislation would delay the reporting of lab payment data by a year and collect recommendations on improving PAMA payment reporting requirements.
In issuing a proposed limited local coverage determination for Opko Health's 4Kscore, Novitas changed course from a previously issued non-coverage determination.
Stakeholders discussed last year's decision by Palmetto to deny coverage for large respiratory panels and discussed the way forward for test developers and labs.
