CMS Streamlines CLIA Certification to Expand COVID-19 Testing

CMS is seeking to expand COVID-19 testing by streamlining Clinical Laboratory Improvement Amendments (CLIA) certification and compliance.

In an announcement late last week, the agency provided a “quick-start guide” detailing the steps laboratories must follow to apply for and receive CLIA certification, which indicates that a laboratory complies with the regulations that ensure the safety and quality of clinical laboratories.

The quick-start guide walks laboratories through the six-step CLIA certification process: completing Form CMS-116, sending it to the appropriate state agency, receiving the fee coupon, paying the applicable fees, receiving certification, and maintaining CLIA compliance.

It also includes information on the expedited review process implemented at the start of the COVID-19 public health emergency that permits laboratories to start COVID-19 testing before the official CLIA paper certificate arrives in the mail.

Additionally, the guide includes instructions on a new CLIA fee payment option.

As part of its efforts to reduce administrative burden and authorization delays, CMS also announced that it will accept online payment from laboratories paying CLIA certification fees. Prior to the online options, laboratories had to send a check to CMS, which take days versus minutes to process.

“An obscure process and outdated modes of payment have too often caused needless delays in certifying lab testing facilities,” CMS Administrator Seema Verma stated in the announcement.

With the new CLIA options, Verma expects “testing laboratories to promptly and painlessly register with CMS so they can get to work, focusing on providing reliable information to combat the spread of this disease.”

COVID-19 testing continues to be a blight on the Trump Administration’s pandemic response strategy.

The US has conducted nearly 101.3 million COVID-19 tests at the time of publication, according to the COVID-19 Tracking Project run by The Atlantic. But that is not nearly enough to contain the virus, industry leaders are saying.

Shortages of testing supplies, including swabs, reagents, tubes, pipettes, and transport media, continues to be a problem for the healthcare industry, the Government Accountability Office (GAO) confirmed in a report released last week.

The shortages are impacting nearly half of all clinical laboratories, the American Association for Clinical Chemistry (AACC) recently reported. Laboratories responding to AACC’s survey also reported delays of up to a week in getting test results back to patients.

“These delays render testing essentially useless in acute patient care and in contact tracing,” AACC stated.

With flu season quickly approaching, the Trump Administration believes getting more clinical laboratories up and running with COVID-19 testing will help to expand the country’s testing capacity.

Under the special expedited review process, once laboratories find a qualified laboratory director and provide all required information on the CMS-116 application, CMS will assign a CLIA number that will permit laboratories to begin COVID-19 testing.

Prior to the pandemic, laboratories had to wait until the paper certificate came in the mail.

AACC is currently reviewing the changes to CLIA certification. But the group has recently called on policymakers to fund lab training programs to prepare the US healthcare industry for future pandemics.

“The coronavirus pandemic has shone a spotlight on how crucial high quality testing is to patient care and public health,” said David G. Grenache, PhD, president of AACC. “But the current crisis has also revealed the weak points in our country’s testing infrastructure, such as the fact that the U.S. has allowed the number of laboratory training programs to diminish for years now. We at AACC strongly encourage Congress to restore funding for these programs so that labs can build up the capacity they need to continue to support the country’s response to public health crises such as COVID-19.”