A Statement by the American Clinical Laboratory Association (ACLA) on CMS’ Proposed Rule on Payment Rates and Policies for Clinical Laboratories

WASHINGTON, DC – The American Clinical Laboratory Association (ACLA) – 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 – released a statement today commenting on the Centers for Medicare & Medicaid Services’ (CMS) 2014 rule announced July 3, that proposes to change payment rates and policies under the Medicare Physician Fee Schedule (PFS) and the Clinical Laboratory Fee Schedule (CLFS).[1]  The proposed changes are expected to take effect January 1, 2015.

The ACLA is pleased CMS acknowledged in the rule it no longer has authority to make adjustments in the CLFS based on technological changes.  The Protecting Access to Medicare Act (PAMA) rescinds this statutory authority, and replaces it with a process to determine Medicare reimbursement for laboratory services based on private payor rates.  ACLA is working closely with Congress, CMS and other stakeholders on this issue, and believes it is critical that the PAMA provisions result in reimbursement rates that reflect the broad scope of the laboratory market, recognize the value of laboratory services, and protect Medicare beneficiaries’ access to diagnostic services.

In addition, we support CMS’ decision not to include provisions from the 2014 proposed rule to base laboratory reimbursement for anatomic pathology services on Outpatient Prospective Payment System (OPPS) rates, acknowledging that approach is not an accurate way to determine appropriate payment rates.  ACLA worked with a diverse group of laboratories, patient advocates, physicians, diagnostic manufacturers and other stakeholders to highlight the flaws of this approach, which would have compromised patient access.  We continue to review CMS’ proposed options in the 2015 proposed rule for gathering and using hospital data.

ACLA has commented to CMS in the past on the inadequacies of the misvalued code process, and we are pleased our recommendations on stakeholder input were included in the proposed rule.  However, we remain concerned about the expanded authority granted to CMS in this area by PAMA, and will be closely monitoring this proposal and actively engaging on behalf of our membership.

Finally, ACLA voiced support for language in PAMA to ensure adequate transparency and opportunity for input in the Local Coverage Determination (LCD) process and continues to review the proposed rule LCD provisions to determine if they are consistent with the goals outlined by Congress and the needs of clinicians and patients.

ACLA continues to review the proposed rule and will file written comments.




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