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While the laboratory industry hopes expanded price reporting will mitigate PAMA's impact, many labs, especially on the hospital side, may not be ready.
CMS has attempted to address stakeholders' concerns about its coverage criteria for germline NGS testing in a new proposed national policy.
The nonpartisan federal agency's report suggests ways for Congress, the FDA, FTC, and CMS to expand oversight of the genetic testing market.
Several years into implementation of the ICD-10 system, payors appear to be tightening coding standards, which some labs say has increased denials.
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.
While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.
The test, TruGraf, assesses differentially expressed genes in blood to rule out subclinical kidney transplant rejection in patients with stable renal function.
The lab can now receive US specimens for testing with its LiquidHallmark blood test that detects cancer-causing gene mutations and viruses.
While the news of the BARDA contract drove a surge in T2's stock price, it was last month's NTAP decision that has company officials and analysts encouraged.
The study said that Cologuard was an "inefficient screening option" for colorectal cancer given its cost as compared to other CRC screening methods.