COVID-19 Testing Payments and Regulations: What Labs Need to Know

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Nov 30, 2020 · By LabReady Team
Announcements support faster testing and tighter regulations around reporting

The pandemic has brought many challenges to our healthcare system, and one of the largest was developing and implementing reliable testing to diagnose COVID-19. Since quick, accurate testing is one of the cornerstones that support public health initiatives, the Centers for Medicare and Medicaid Services (CMS) raised reimbursement to $100 in April for high-throughput testing. A recent announcement from CMS outlined a new high-throughput testing payment scheme for 2021. The base rate for COVID testing will be $75 beginning January 1st. Labs that can achieve a two-day turn-around time (TAT) for results will receive a $25 add-on payment per test, bringing total reimbursement to $100. The HCPCS code for the add-on payment will be U0005. Labs that fail to meet the TAT will receive the base payment only.

CMS also recently released an Interim Final Rule regarding COVID testing and reporting. In addition to labs, the rule has provisions covering all facilities that use a CLIA Certificate of Waiver, including private physician offices, nursing homes and pharmacies.

The Interim Final Rule covers a wide breadth of subjects that include not only COVID testing but also amendments to MIPS (Merit-based Incentive Payment System) measures and information regarding the monetary burden of test result reporting. CMS has investigated the far-reaching financial and clinical effects of testing during the pandemic. As a result, many of the new rules and regulations are engineered to reduce fraud opportunities associated with COVID testing and assure all testing results are reported accurately and with appropriate frequency.


  • A new monetary penalty can be imposed on long-term care facilities (LTCs) for failing to report COVID-19 data.
  • LTCs are required to test all residents and facility staff according to parameters set forth by the Secretary and coordinate with state and local health departments about the availability of testing supplies.
  • “Tests (will be) covered when ordered by a pharmacist or other healthcare professional who is authorized to order diagnostic laboratory tests (per) state scope of practice and other pertinent laws.”
  • Limitation to one instance of diagnostic testing (ordered without a physician or other practitioner) for influenza and respiratory syncytial virus (will be) covered when performed in conjunction with a COVID-19 test to establish or rule out a diagnosis.
  • FDA-authorized COVID-19 serology tests are covered when medically necessary.
  • All CLIA labs, and facilities that are CLIA-Waived and use Point-of-Care testing, must report COVID test results in a standard format.
  • Failure of labs to report test results could incur monetary penalties.

To read the full article on the Quadax website, click here.

For more information about Covid-19 testing, or to discuss these ideas, click here to connect with a LabReady team member.

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