A Statement from the American Clinical Laboratory Association (ACLA) on the Clinical Laboratory Fee Schedule (CLFS) provisions in the SGR Extension Legislation

WASHINGTON, D.C. – The American Clinical Laboratory Association (ACLA) — a not-for-profit association representing the nation’s leading national and regional clinical laboratories on key issues of common concern, including federal and state government reimbursement and regulatory policies –issued the following statement regarding the Clinical Laboratory Fee Schedule (CLFS) provisions in the SGR extension legislation that was posted in the US House of Representatives earlier today.

ACLA offers its support to the SGR extension legislation’s CLFS reform provision (Section 216) as it will provide for a more rational process for transitioning to changes in CLFS reimbursement. ACLA also supports the extension of the SGR to ensure that Medicare reimbursement for anatomic pathology services will not suffer significant cuts.

“We are pleased that Congress listened to and included many of our key priorities in this proposal for modernizing how Medicare reimburses clinical laboratories,” said Alan Mertz, President of the ACLA. “If adopted, this proposal would preserve seniors’ access to diagnostic testing by avoiding another potential round of indiscriminate across-the-board payment cuts, and bringing some much-needed predictability in reimbursement over the next several years. This legislation will provide more transparency, and more time for laboratories and other stakeholders to prepare for changes. It will also provide more opportunity for stakeholders to work with the Centers for Medicare and Medicaid Services (CMS) on implementing these important reforms.”

Specifically, the proposal repeals CMS authority to make changes to the CLFS based on technological changes and replaces it with a process to adjust reimbursement based on market rates, provides a per test phase-in of reductions in reimbursement, creates a payment adjuster for laboratories serving the most vulnerable Medicare beneficiaries, and requires a clearly defined, transparent process for reconsideration of CLFS rates.

The clinical laboratory industry considers this legislation a better alternative to the current CMS adjustment process which was unlimited, and did not allow enough time for stakeholder input, and lacked transparency. The legislation also avoids the across the board cuts to which clinical labs have repeatedly been subject.

“Clinical laboratories provide the critical information needed for 70% of physician decisions and aid early diagnosis and treatment of chronic diseases that, when caught early, prevent years of increasing costs to the healthcare system,” stated Mertz. “Yet, despite this critical role in the diagnosis and treatment of disease, clinical laboratories have been subjected to repeated cuts in Medicare reimbursement in the past. These cuts, in addition to the threat of further unrestricted adjustments by CMS through an adjustment process announced last year, threatened innovation and patient access to important laboratory services.

The statement concludes:

“We are committed to continuing to work with Congress, CMS and other stakeholders in reforming the CLFS while ensuring that the process reflects the actual broad scope of the laboratory market, recognizes the value of laboratory services and protects access for Medicare beneficiaries,” concluded Mertz.

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