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The effort is one of five being undertaken by MDIC's Clinical Diagnostic Program designed to expedite the regulatory process for clinical diagnostics.

The unique, test-specific PLA codes make it easier for insurers to identify tests and apply positive or negative coverage policies, billing experts say.

Newly announced changes will enable more hospital outreach laboratories to submit lab pricing data, but lab groups say more changes are needed.

The Tulsa, Oklahoma-based lab, which received its CLIA license in August, will run samples reimbursed by Medicare and state Medicaid agencies only. 

Palmetto GBA issued final local coverage determination for the tissue-based, 31-gene expression test, which determines a patient’s risk for metastatic disease.  

Smaller multiplex molecular panels of five or fewer targets will be covered, while a determination of gastrointestinal panel coverage is expected soon.

While acknowledging the lab industry's argument had merits, a judge agreed with the government that the court had no jurisdiction in the case. 

The association says a provision requiring MACs to independently review LCDs from other jurisdictions before adoption is critical to the legislation.

While almost 57,000 labs received Medicare payments for labs performed last year, just three labs received 15 percent of the total Medicare lab payments.

Changes to the checklist included restructuring requirements related to analyte-specific reagents and laboratory-developed tests to reduce redundancy.

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