Advocacy - Lab Advocate
On August 24th, the AACC provided input on the Centers for Medicare and Medicaid Services’ (CMS) proposed rule which suggests a number of changes to CLIA regulations. While the association supports the agency’s efforts to update the standards, it has concerns about several of the recommendations.
The agency has proposed changes to staff training and educational requirements such as adding nursing as a qualifying degree under the moderate and high complexity testing personnel requirements. AACC believes that nurses are invaluable members of the healthcare team but opposes this change as their education and training does not adequately address the scientific concepts that underly clinical laboratory testing. Requiring nurses to demonstrate competency through passing a curriculum of lab specific courses or competency exams should be required to allow them to perform this testing.
CMS also proposes changing the qualifications for a high complexity laboratory director (HCLD) to include “professional doctorates” and individuals with a “master’s equivalency,” who meet certain training, experience, and certification requirements. The agency states that a Doctorate in Clinical Laboratory Science (DCLS) would fulfill the requirement as a professional degree. However, CMS and other CLIA approved certifying agencies have historically not recognized this degree as acceptable for becoming an HCLD.
AACC and other physician and laboratory groups opposed expanding the HCLD qualifications arguing that the research component of a PhD is critical to developing the skills need to design, troubleshoot, and build new tools needed by physicians to treat their patients. The association added that CMS should have held a public forum with all the interested and affected stakeholders to discuss this suggestion before publishing it in the Federal Register.
CMS is also proposing to update CLIA fees, a subject which AACC agrees should be reassessed, but with careful consideration given the cost pressures labs are experiencing under the Protecting Access to Medicare Act (PAMA) and from other sources. The current methodology has been in place since 1992 however, labs have been forced to accommodate for inflationary pressures and residual supply shortages. The proposed reduction for reimbursement under PAMA would likely put further strain on the ability of labs to conduct high quality testing for patients in underserved areas.
While AACC supports the agency’s nominal increase in the Certificate of Waiver (CoW) user fee, the association believes the additional revenue should be used to reinstitute the agency’s annual inspections of CoW facilities which have significantly proliferated over the last few years. The association is dedicated to ensuring access to making quality testing available and will continue to engage with CMS and other federal agencies to provide input that benefits patients and the laboratory community.