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.
A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractors.
When used together, ThyGeNext and ThyraMir combine next-generation sequencing of an individual's DNA and RNA along with a microRNA classifier.
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.
A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractor Palmetto for the week of 8/22/2019.
The Medicare contractor has proposed to cover the non-invasive test for certain kidney and heart transplant patients.
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.
For the three months ended June 30, the genomic testing firm reported total revenues of $30.1 million.
The company decided to settle the complaint in order to avoid "lengthy and distracting litigation," but denies any wrongdoing.
The letter supporting the LAB Act, which would delay reporting of lab payment data under PAMA, was submitted to the House Energy & Commerce Committee.
Though the designation has seen slow uptake thus far, three tests received ADLT status in May, bringing the total number of approved ADLTs to five.
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.