CMS Planning Significant Increase in CLIA Fees

On the last day of 2018, the Centers for Medicare and Medicaid Services (CMS) published a Notice in the Federal Register to increase the fees the Agency charges clinical laboratories to defray the costs of administering the Clinical Laboratory Improvement Amendments (CLIA) program. CMS has not increased the fees covering the cost of administering the CLIA program since 1992.

With this Notice, CMS would increase current CLIA fees by 20 percent to close the gap between current obligations and current collections. ASCP is concerned about the increase in CLIA fees, especially given the additional round of 10-percent cuts in the Clinical Laboratory Fee Schedule (CLFS) imposed by Section 216 of the Protecting Access to Medicare Act of 2014. (See related story in this issue of ASCP’s ePolicy.)  ASCP is reviewing the notice and consulting with its leadership on a response.

CLIA requires CMS to impose two separate types of fees: ‘‘certificate fees’’ and ‘‘additional fees.’’ Certificate fees are imposed for the issuance and renewal of CLIA certificates and must be sufficient to cover the general costs of administering the CLIA program, including evaluating and monitoring approved proficiency testing (PT) programs and accrediting bodies and implementing and monitoring compliance with program requirements. Additional fees are imposed for inspections of non-accredited laboratories and for the cost of performing PT on laboratories that do not participate in approved PT programs.

Fees for the issuance of registration certificates would not be increased as these increases would not have substantial impact on the Agency’s costs. CMS will be accepting comments on the notice through March 1, 2019. To access CMS’s fact sheet on the fee increase, click here.

Other articles in ePolicy News January 2019

ASCP’s NPQR Awarded QCDR Status by CMS for 2019

Choosing Wisely to Recognize the ‘Champions’ Driving Innovation in Health Care

Sickle Cell Disease Bill Becomes Law

CMS Gears up for Second PAMA CLFS Reporting Requirement

To read more articles from ePolicy News click here.

For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202) 408-1110.

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