AdvaMedDx Statement on Introduction of House Bill on Diagnostics Payment Reform

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AdvaMedDx Statement on Introduction of House Bill on Diagnostics Payment Reform

October 4, 2012

WASHINGTON, D.C. – A bill on diagnostics payment reform recently was introduced by Reps. Peter J. Roskam (R-Ill) and Leonard Lance (R-NJ) and cosponsored by Rep. Richard E. Neal (D-Mass).  The new legislation, HR 6446, aims to address flaws in the current system for reimbursing diagnostic manufacturers.  The text of the bill can be viewed here

This proposed legislation was crafted to improve the archaic process for determining Medicare payment rates for new tests, which should create meaningful incentive for manufacturers of innovative diagnostics. Some background:

  • Medicare’s outdated Clinical Laboratory Fee Schedule not only determines reimbursement for diagnostic tests covered under Medicare, it is also the standard looked to by all private insurers as they determine reimbursement rates.
  • Diagnostic tests are critical to medical decision making at all stages of patient care, from diagnosis and treatment to prognosis and follow up care.  Innovative new technologies including revolutionary molecular and genetic assays being developed based on the human genome that can treat critically ill patients are being reimbursed based on a flawed system that stifles further investment and innovation.
  • The text of HR 6446 replicates the diagnostic-reform language from the previously introduced MODDERN Cures Act (HR 3497), which would reform diagnostics payment for new tests by establishing new payment-setting criteria that incorporates elements of market value and takes into account the contribution of diagnostics to health care outcomes.  This new stand-alone bill is expected to have widespread bipartisan support. 

At this time, HR 6446 has been submitted to the House Energy and Commerce Committee, as well as the Ways and Means Committee. AdvaMedDx will continue to track its progress.

For more information, please contact: Ashley McMaster @ (202) 434-7245


AdvaMedDx member companies produce advanced, in vitro diagnostic tests that facilitate evidence-based medicine, improve quality of patient care, enable early detection of disease and reduce overall health care costs. Functioning as an association within AdvaMed, AdvaMedDx is the only multi-faceted, policy organization that deals exclusively with issues facing in vitro diagnostic companies both domestically in the United States and abroad. For more information, visit