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The LCD for the RNA gene expression test will take effect on Feb. 10, 2020, the Medicare contractor said.

Despite the availability of more precision therapies and complex biomarker tests, systemic gaps and lack of physician education continued to hinder access.

While legislation and lawsuits sought to blunt PAMA's impact, labs also employed new technologies and strategies to cope with anticipated price cuts.

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.

The company's newest products and planned updates reveal a focus on operational efficiency and increasing automation for core lab management.  

 

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.

A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractors.

 

The LCD will provide coverage for the Decipher Prostate Biopsy genomic test for men with both favorable and unfavorable intermediate-risk prostate cancer. 

The test will now be considered medically reasonable and necessary for patients over 45 with moderately elevated levels of prostate-specific antigen. 

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. 

Recent local coverage determinations from Medicare Administrative Contractors, posted Nov. 1, 2019.

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.

Several years into implementation of the ICD-10 system, payors appear to be tightening coding standards, which some labs say has increased denials.

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.

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