ACLA News

ACLA Comments on Bucshon-DeGette Discussion Draft Impacting the Regulation of Clinical Laboratory Diagnostics

(Washington, D.C.) –  Today, the American Clinical Laboratory Association (ACLA) submitted comments in response to a discussion draft, the Diagnostic Accuracy and Innovation Act (DAIA), recently released by Representatives Larry Bucshon, M.D. (R-IN) and Diana DeGette (D-CO).  ACLA’s comments reiterate the association’s continued support of comprehensive statutory reform to create a distinct framework for clinical laboratory diagnostics that advances innovation and protects patients, including for both laboratory developed test services (LDTs) and in Vitro diagnostic (IVD) test kits.

“ACLA thanks Representatives Bucshon and DeGette for their leadership in advancing comprehensive reform and appreciates the opportunity to comment on the discussion draft,” said Julie Khani, president of ACLA.

Clinical laboratories, including ACLA members, have been at the forefront of diagnostic innovation, including molecular and genetic diagnostics.  These powerful tools help guide physicians and patients, not only in screening and diagnosis, but also in disease prevention and treatment.

“We believe a successful reform effort should include clear grandfathering and transition policies so that patient access is not hampered, while balancing paths for innovation with assurances for accuracy and reliability,” said Khani. “The DAIA discussion draft contemplates many of these policies important to industry stakeholders. We look forward to continuing work with the Energy & Commerce Committee, the Health, Education, Labor & Pensions (HELP) Committee, and other stakeholders on the best path to strengthen the regulatory framework for clinical laboratory diagnostics without disruption to patient care.”

Click here to view ACLA’s comments on the DAIA.

 

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The ACLA is a not-for-profit association representing the nation’s leading national, regional and esoteric clinical laboratories on key issues of common concern, including federal and state government reimbursement and regulatory policies.