CMS recently announced a 20 percent increase to the fees that laboratories must pay when certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. This is the first such increase in the last 20 years and is meant to address the significant CLIA program administration shortfall that has developed over time. The increase was issued in a notice with comment period that was published in the Federal Register on December 31, 2018. The fee increases are effective immediately, but comments are due by March 1, 2019.
CLIA applies to all laboratories that perform tests on human specimens to provide information regarding the diagnosis, prevention, treatment, or assessment of health. Clinical laboratories are required to obtain CLIA certification based on the type of diagnostic tests conducted. To participate, CLIA requires that laboratories pay “certificate fees” (for the issuance and renewal of CLIA certificates), “compliance fees” (for the monitoring of testing and conducting onsite inspections) and “additional fees” (for, e.g., validation inspections of non-accredited laboratories). The fee amounts vary based on factors such as dollar volume and scope of testing being performed at the laboratory. All three types of fees are subject to the 20 percent increase. In three tables in the Federal Register, CMS demonstrates the fee increase for different laboratory classifications. For example, certificate fees will jump from a range of $150–$7,940 (depending on laboratory class) to $180–$9,528.
CMS has “monitored” CLIA operation costs, including state survey agency awards, administrative costs, and contract support, and observed an approximately $9.3 million shortfall in expenditures as compared to fee collections as of fiscal year (FY) 2017. In part, CMS noted, the increase in costs related to the increase in the amount of time required to survey laboratories conducting complex testing. Without a fee increase, CMS predicted that the CLIA program would “cease to be self-sustaining” by 2020, which will “potentially compr[omise] public health and safety.” The 20 percent increase is expected to increase fees by $10.2 million in FY 2018 and sustain the CLIA program through 2021. CMS estimated that this increase will impact approximately 250,010 CLIA-certified laboratories.
CMS previously solicited comments regarding updating CLIA fees on January 9, 2018 (Request for Information). CMS stated that it will use the comments received in response to the Request for Information and this latest Notice in future rulemaking. Nonetheless, the fee increases are effective immediately.
The Federal Register notice with comment period is available here. The CMS Fact Sheet is available here. The January 9, 2018 Request for Information is available here.
