WASHINGTON, D.C. – In response to a Request for Information (RFI) from the House Energy and Commerce Committee for the 21st Century Cures initiative, the American Clinical Laboratory Association (ACLA) stated in a letter dated June 1, 2014 that clinical laboratories are centers of diagnostic innovation, providing diagnostic services that guide 70 percent of all medical decisions made by health care providers and are helping to advance personalized medicine though scientific research and innovative lab testing. The letter states in part:
From a clinical standpoint, clinical laboratory diagnostic services furnish patient-specific clinical information that guides more than 70% of all medical decisions made by health care providers. Clinical laboratory tests provide objective information on the functioning of the human body, so that patients can be diagnosed, treated, or monitored precisely and as quickly as possible. The information provided by these tests, which are performed on samples of a patient’s tissues or fluids, provide the necessary data for physicians to make informed decisions and best direct patient care.
Over the last few decades, laboratory medicine has seen many exciting advances in the areas of cancer, infectious disease, rare disease, and numerous other health conditions, which are helping us to realize the goal of personalized medicine. These advances have fundamentally changed our understanding of the mechanisms of disease, enabling physicians to diagnose conditions more precisely, detect the onset of disease earlier, target patient treatments more effectively, monitor disease progression, and predict individual predisposition to disease due to genetic or molecular factors. Simply put, clinical laboratory services are providing more accurate diagnoses, quicker; allowing physicians and patients to choose the best treatment, first and sooner; and, in the process, increasing the quality of life, lowering costs, and saving lives.
On May 1, the House Energy and Commerce Committee launched its call to action for the 21st Century Cures initiative, noting, “If we want to save more lives and keep this country the leader of medical innovation, we have to make sure there is not a major gap between the science of cures and the way we regulate these therapies.” The Committee is planning to issue a series of white papers seeking input and soliciting ideas on how Congress can help accelerate the discovery, development, and delivery of promising new treatments to patients. It will also examine existing regulatory policies and evaluate their impact as to whether they facilitate or hinder medical innovation.
In the letter, ACLA references the current “three part framework consisting of federal regulations under the Clinical Laboratory Improvement Amendments (CLIA), state laws, and accreditation by deemed authorities such as the College of American Pathologists. This regulatory framework requires both extensive validation and oversight to ensure quality of diagnostic services, yet allows laboratories the flexibility to develop and validate lab tests quickly and, thus, more quickly adopt new scientific knowledge and rapidly respond to unmet public health needs.”
However, ACLA also addresses the challenges clinical labs face: “Like other health care sectors, the clinical laboratory industry faces pressure from all sides, whether for lower prices and less robust insurance coverage of services or whether from calls for increased, even duplicative oversight and overly cumbersome standards for introducing innovative new technology and medical knowledge.”
The letter concludes: “Grounded in our long history of innovation and commitment to patient care, ACLA looks forward to partnering with the Energy and Commerce Committee and other stakeholders to highlight the critical role of clinical laboratory services in increasing health care value and advancing innovation. We are committed to working with you to ensure patients have access to ever higher quality health care.”
Click here to view the letter in its entirety.