Compliance with Final PAMA Rules - Advanced Diagnostic Laboratory Tests: What Considerations for Launching a New Test?

The final PAMA rule was released June 17 and will require laboratories and physician offices to begin reporting information on the payments they receive from private payers starting January 1, 2017. Join Arnold & Porter and XIFIN, Inc.'s for an in-depth webinar series, "Compliance with Final PAMA Rules for Clinical Laboratories." This regulation will transform Medicare's payment system for clinical laboratory testing while establishing significant new compliance demands. Arnold & Porter and XIFIN, Inc. have partnered to create a series of three in-depth webinars that help laboratories prepare to comply with the rules and succeed in the new reimbursement environment.

PAMA gives special treatment to Advanced Diagnostic Laboratory Tests (ADLTs) including unique billing codes, Medicare payment at their list price at launch, and annual rate changes. To obtain ADLT status, laboratories must submit an application to CMS and prove that their test provides new clinical information that can't be gotten from other tests. CMS will give G codes to ADLTs and unique identifiers to laboratories for FDA-approved tests, but the process for getting them is unclear. And which of these steps should laboratories take first when launching a new test?