Most Americans have been making paperless payments, purchases and other transactions for years. The program for certifying clinical laboratories is finally taking that route itself.
Under the change taking effect March 1, the Centers for Medicare & Medicaid Services (CMS) ends paper CLIA certificates and coupons. Laboratories will be required to receive all CLIA communications electronically and submit payments exclusively through pay.gov.
Medical labs that require CLIA certification will need to register with CMS to receive communications only by email. The agency will no longer send out CLIA coupons or certificates by postal mail.
Double check that lab contact information is current
Because CMS ends paper CLIA certificates and coupons under the new policy, laboratory managers must ensure their contact information is current with CMS, state agencies, and accrediting organizations to avoid lapses in certification.
There are five certifications issued under CLIA. Three are for registration; compliance; and accreditation. There is also a certificate for provider-performed microscopy and a waiver for performing simple testing. Fees for the compliance and accreditation certificates range from $223 for a low-volume lab (less than 2,000 tests performed annually) to $11,801 for a high-volume lab (1 million or more tests per year). The registration, waiver and PPM certifications run $123, $248 and $297 apiece, respectively.
All payments for certifications, coupons and other fees will also only be accepted electronically at the pay.gov website.
Going paperless ‘creates a foundation for better documentation’
“Moving toward a paperless CLIA environment is an important first step in strengthening regulatory compliance while improving efficiency and consistency across laboratory operations,” said Eva Schenkman, PhD, CLT (NYS), ELD/HCLD (ABB), a North Carolina-based embryologist who serves as the laboratory director at the University of Oklahoma. “It creates a foundation for better documentation, clearer accountability, and more streamlined workflows, allowing laboratories to focus more of their effort on quality, accuracy, and patient care.”
Although Schenkman noted that most labs have already moved away from paper, there are still many that use it in everyday operations, she added.
A spokesperson with the American Clinical Laboratory Association did not immediately respond to a request seeking comment about how the transition is impacting their membership.
CMS has said it will work with state agencies and accrediting organizations through May 2026 to assist clinical laboratories that miss the deadline, even as the agency ends paper CLIA certificates and coupons in favor of electronic communications.