(Washington, D.C.) – The American Clinical Laboratory Association (ACLA) today applauded the President’s FY 2016 Budget for including the removal of anatomic pathology (AP) from the Medicare in-office ancillary services (IOAS) exception to the federal self-referral law, noting it protects patients and the clinical lab profession. This is the third consecutive year the provision has been included in the President’s annual budget.
“The clinical laboratory community has long supported excluding anatomic pathology from the IOAS exception as a policy that best serves the patient and fosters integrity among lab professionals in a field that is a leader on the frontier of personalized medicine,” said Alan Mertz, President of the ACLA. “As clinical diagnostics continue to play a critical role in a new healthcare era, it is essential to have the public trust and adhere to the highest level of ethics.”
ACLA is a founding member of the Alliance for Integrity in Medicare (AIM), which strongly supports removing AP from the IOAS exception as well as advanced diagnostic imaging, radiation therapy and physical therapy. A July 2013 GAO report found that self-referral for anatomic pathology services increases utilization and unnecessarily drives up Medicare spending. ACLA noted that the IOAS provision would save the Medicare program an estimated $6.02 billion over 10 years. Further support for Medicare self-referral reform was recently cited in the Journal of the American Medical Association (JAMA) in an analysis of the issue, its original intent and the impact of the exceptions on the medical profession.
In addition to commending the removal of AP from the IOAS exception, ACLA reiterated its support for new funding for next generation gene sequencing that was part of the President’s recently announced Precision Medicine Initiative. Applauding the investment for research and innovation, ACLA also pointed to the conflict in policy direction with respect to the Food and Drug Administration’s (FDA) current move to regulate laboratory developed tests (LDTs). FDA regulation of LDTs would duplicate existing oversight and dramatically slow the time between the development of life-saving therapies and patient access to treatment.
“ACLA supports the proposed $200 million in new funding for the NIH, including $70 million to the National Cancer Institute,” said Mertz. “This funding could lead to groundbreaking discoveries and ultimately, improved clinical outcomes for patients. However, ACLA has been clear and unambiguous in our opposition to FDA regulation of laboratory-developed testing services, including those involving next generation sequencing.”
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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.