CMS considering first revisions to lab rules in 26 years
The CMS is taking a hard look at whether regulations governing clinical laboratories need to be updated. Industry groups hailed the move, which they say is long overdue.
The Clinical Laboratory Improvement Amendments outline standards for U.S. facilities or sites that test human specimens for health assessments, as well as to diagnose, prevent or treat disease.
The CMS posted an request for information on Friday asking the industry for input on how the policies should be updated. Specifically, the agency is interested in whether personnel requirements, testing standards and industry fee structures need to be updated.
The notice comes as the CMS is implementing a new policy to pay labs the same rate for tests as private payers. Labs expect to lose $670 million due to the rate change. Prior to the new payment rule kicking in Jan.1, Medicare's fee schedule for lab tests had been largely unchanged since it was established in 1984.
While fighting the payment rule in court, lab industry stakeholders praised the release of the request for information.
"The CLIA regulations have not been meaningfully updated for about a quarter of a century," said Rodney Rohde, chair and professor of clinical laboratory science at Texas State University. "This notice will be the beginning of a process, that we hope, will create a regulatory environment that improves patient care and gives laboratory professionals an opportunity to have a growing impact on the efficacy of diagnostic decisionmaking and treatment."
Rohde has been a leading voice on the national stage about an increased reliance by clinical labs on undertrained staff to perform and analyze increasingly complicated tests.
Those concerns have only grown among the industry following a 2016 agency guidance that declared a degree in nursing is equivalent to a degree in the biological sciences.
Major trade groups like the American Society for Clinical Laboratory Science and American Society for Clinical Pathology have been lobbying the CMS to reverse course, arguing that nurses do not take the same amount of scientific coursework necessary to conduct and analyze complex laboratory tests.
Industry is hopeful that the request for information will give them the platform needed for their concerns to be fully vetted and heard by the CMS.
"We want to make sure that whatever lab tests are performed, they are performed properly," said Jim Flanigan, executive vice president at the American Society for Clinical Laboratory Science. "When we look at current regulations we see gaps in ensuring laboratory tests are properly conducted and reported out to the clinician making treatment decisions."
Industry groups also plan to push for allowing third-party organizations to confirm that lab personnel meet the education and training requirements of the regulations, according to Michael McCarty, counsel for American Medical Technologists, a national certification organization and professional society for clinical laboratory technologists.
CLIA surveyors have to document that lab personnel have the required level of education and training for the highest complexity level of testing they perform. "For lab personnel who completed their formal education many years ago, which is an increasing percentage of the workforce, it can be burdensome to produce their original diploma or transcript,"McCarty said.
"If CMS accepted private certifications it would provide for a much more streamlined process for surveyors to verify that personnel meet the CLIA requirements," he said.
The CMS is accepting responses on the request for information through March 9.
Send us a letter
Have an opinion about this story? Click here to submit a Letter to the Editor, and we may publish it in print.