Despite the availability of more precision therapies and complex biomarker tests, systemic gaps and lack of physician education continued to hinder access.
The bill, which will delay reporting of lab payment data required by PAMA, will now be passed on to the President, who is expected to sign it into law.
Efforts to pass a nationwide surprise billing law appear stalled for now, but state laws and proposals for federal legislation still loom large for labs.
While pass-through billing has long been a regular part of the lab landscape, some newer arrangements run afoul of payor policies and anti-kickback laws.
The LCD will provide coverage for the Decipher Prostate Biopsy genomic test for men with both favorable and unfavorable intermediate-risk prostate cancer.
The insurer's move to equalize rates across all lab sites has particularly impacted hospital-based facilities, which have typically received higher reimbursement.
Medicare contractor Novitas has been considering a limited local coverage determination for the test, which calculates PSA values and determines whether a patient may need a prostate biopsy.
While the laboratory industry hopes expanded price reporting will mitigate PAMA's impact, many labs, especially on the hospital side, may not be ready.
Companies in the AMR space have met resistance from investors and clinicians as a result of conflicting hospital priorities and perceived technology shortcomings.
ACLA filed a motion arguing that HHS' PAMA data collection process is flawed. It follows a July decision that overturned a lower court's dismissal of ACLA's lawsuit.
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.
