(Washington, D.C.) – In a letter to Vice President Joe Biden following the administration’s release of the FY 2017 budget including a proposed billion dollar funding of the Moonshot initiative aimed at accelerating the effort to cure cancer, the American Clinical Laboratory Association (ACLA) emphasized the expanded role of diagnostic innovation in the research and treatment of cancer and urged the vice president to reject regulatory and payment and coverage proposals that could hinder advances in the development of and patient access to diagnostic tests.
Specifically, ACLA cites the proposed Food and Drug Administration (FDA) guidance to regulate laboratory developed tests (LDTs), many of which are accurately identifying and guiding the appropriate treatment of various cancers including breast, colon, leukemia and lymphoma, as a hindrance to ongoing scientific advances in diagnostics.
In addition, the letter states:
The impact of federal policy regarding coverage for and payment of clinical laboratory tests has significant repercussions in the present and in the future for the prevention, diagnosis, treatment, and the ultimate cure for cancer. If the Task Force wants to meet its stated goals, then improvements must be made swiftly to both coverage and reimbursement rates for clinical laboratory test services.
“ACLA applauds the administration’s leadership in proposing a greater emphasis on finding the cure for cancer,” said Alan Mertz, President of the ACLA. “If accelerating research efforts to find the cure for cancer is the main objective of Moonshot, then the administration must respectively reject FDA guidance to regulate LDTs and support logical payment reforms for diagnostic tests that are saving patient lives and fueling the personalized medicine movement.”
To read ALCA’s letter to Vice President Biden, click here.
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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.