Advocacy - Lab Advocate
In late December, key members of the House and Senate wrote to the Centers for Medicare and Medicaid Services (CMS) urging the agency to make significant changes to its October 1, 2015, proposed rule implementing the clinical laboratory provisions of the Protecting Access to Medicare Act (PAMA). The law directs the agency to rebase the clinical laboratory fee schedule to reflect private sector payment rates while creating a new payment category to reward innovative tests. Like Congress, AACC and many in the health community have raised strong objections regarding CMS’ approach.
The statute requires the agency to gather data from clinical laboratories on the fees paid by private insurers for each test they perform. This information will be used to set the new test payment rates. CMS proposes to exclude hospitals and smaller testing facilities from the reporting requirements. These laboratories typically receive higher payment rates since they do not offer volume discounts. By excluding these data, the agency is likely to set overall outpatient fees for all testing facilities that are lower than anticipated. Further, without explanation, the agency is excluding protein biomarkers from the definition of the new Advanced Diagnostic Laboratory Tests payment category—even though the statute requires higher payments for these biomarkers when used in conjunction with “a unique algorithm” that yields single patient-specific results.
In response to these ‘questionable’ decisions, more than 60 House and Senate lawmakers informed CMS of their objections to CMS’ proposed rule, particularly the exclusion of hospitals from the reporting requirements and the arbitrary elimination of protein biomarkers from the new payment category. In addition, the legislators also questioned CMS’ timeframe for adopting the proposal. AACC expressed similar concerns in its November 24 comments to CMS. The Association urges CMS to work with all stakeholders to develop and implement a fair and realistic approach to adopt the PAMA laboratory provisions.