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

November 03, 2020 By: Quadax

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 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.


Highlights from the Rule:

  • 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.

Other important pieces of information to note:

  • Temporary testing sites used by labs are still compliant as long as specific criteria are met.
  • Laboratories can refer to the FDA website for information on testing using different specimen collection devices when deviating from manufacturer's instructions.
  • Specific requirements for nursing facilities have been put into place. Testing frequency will be based upon community COVID-19 activity. Activity should be checked every other week.

Use resources to help you navigate changing rules and regulations

Since the Public Health Emergency (PHE) declaration on March 13, 2020, healthcare providers of all types have had to pay close attention to information about COVID-19 for both clinical and financial updates – and the information can be overwhelming. The CMS Laboratory FAQ webpage is a comprehensive source of guidance, as well as professional groups such as the American Clinical Laboratory Association (ACLA).

Another place to look for support is your revenue cycle partner. Especially in the current environment of quickly changing rules and regulations, the most valuable partners have experience in a variety of laboratory billing and industry challenges and have their finger on the pulse of new rules and regulations. One criterion to look for in an RCM partner is confirmation that they incorporate the evolving standards under the Protecting Access to Medicare Act (PAMA) into their workflows. If you are a lab that fulfills the requirements, your partner should support your efforts to be compliant by supplying you with final payment data and seamless submission to CMS after approval.

About Quadax

When your reimbursement resources are being pushed to the limit and the ever-changing payer landscape threatens your financial goals, having the right revenue management partner can protect your organization’s revenue and cash flow. Quadax helps you navigate the specific challenges that impact hospital and independent lab operations, so your lab can deliver exceptional clinical value to patients and clients. Learn more about how Quadax can ensure optimized reimbursement focused on quality and cash collections.

Let’s take on the revenue cycle together!

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