Today, legislation introduced by Rep. Michael G. Grimm (R,C-NY), the Taking Essential Steps for Testing Act, or TEST Act (H.R. 6118), passed the House with unanimous support. This legislation modifies the Clinical Laboratory Improvement Amendments (CLIA), to ensure labs that conduct human specimen testing do not lose their license (or CLIA certificate) when they accidentally send out a test sample to another lab. In recent cases, an honest mistake that causes no threat to patients has resulted in hospitals and labs losing their license for two years -- a result that costs millions of dollars. Rep. Grimm's bill changes the mandatory revocation of the CLIA certificate to allow the Centers for Medicare and Medicaid Services (CMS) to revoke on a case-by-case basis. This is Rep. Grimm's seventh bill to pass the House.
"The TEST Act tweaks a well-intended law and rids it of the unintended negative consequences imposed by an overzealous regulation," said Grimm. "While the current regulation was well-intended to ensure reliable lab results from the most basic test to the most life-threatening, it can turn an honest mistake into a disaster for our healthcare providers. Without a CLIA certificate, labs are unable to conduct any human specimen testing. For our already cash-strapped hospitals, this could mean choosing between shutting down services like the ER or operating room or paying millions of dollars to bring in an outside lab for 2 years. While New York's labs have remained in the clear as the administration continues its aggressive enforcement, there is nothing stopping CMS from going after them tomorrow. The TEST Act proactively protects them, while helping others who have been impacted throughout the U.S."
Under the Clinical Laboratory Improvement Amendments, any lab that conducts human specimen testing must have a CLIA certificate and comply with the law's proficient testing (PT) requirements. CLIA requires labs to treat PT sample as it would a patient sample. However, the law explicitly prohibits a lab from referring a PT sample to another lab - although this may be the normal patient procedure.
The purpose of this prohibition is to ensure labs submit their own results for PT samples. This promotes continued patient safety, accurate results, and that a lab is not getting reimbursed for tests it does not, or cannot, perform.
The concern that this bill seeks to address is that labs which have accidentally referred a PT sample to another lab and self-reported this mistake, are being told by CMS that CLIA does not provide any flexibility and their certificate must be revoked. As a result, labs that make a mistake and proactively try to correct it are treated identically to labs which knowingly, and in bad faith, violate the law. Without a CLIA certificate, labs are unable to conduct any human specimen testing and must shut down for 2 years, resulting in reduced access to healthcare and related services.
The TEST Act gives CMS discretion not to revoke a CLIA certificate for a PT referral if it is determined that the lab was acting in good faith. For labs which are bad actors, the TEST Act does nothing to alter CMS's ability to punish those labs and revoke their certificate. H.R. 6118 also gives CMS the discretion not to apply the revocation to an entire hospital network or other owner operator based on the facts of the particular case.