The provider needs to indicate a diagnosis(es) on the requisition form. An independent clinical laboratory cannot append or amend a diagnosis code to the patient's medical record without written documentation confirming the change in diagnostic code, and that the diagnosis code is in the chart. COVID diagnostic codes- whether for the Molecular PCR testing or the serology testing are established, as Thomas states above with other clinical criteria. The package inserts of every test that is being done contain a disclaimer that states....
Taken from Quest EUA Authorization Letter- Link Below - each manufacturers insert is different.
"Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses."
Authorized laboratories that receive Quest SARS-CoV-2 rRT-PCR test must notify the relevant public health authorities of their intent to run the test prior to initiating testing.
Authorized laboratories using Quest SARS-CoV-2 rRT-PCR test will have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate.
Quest Diagnostics and authorized laboratories using Quest SARS-CoV-2 rRT-PCRT test will ensure that any records associated with this EUA are maintained until otherwise notified by FDA. Such records will be made available to FDA for inspection upon request
No advertising or promotional descriptive printed matter relating to the use of Quest Diagnostics” authorized Quest SARS-CoV-2 rRT-PCR test may represent or suggest that this test is safe or effective for the detection of SARS-CoV- 2
https://www.fda.gov/media/136228/download
The ordering provider should be following the CDC's guidelines for establishing the Priority of patient testing, and clinical laboratories performing diagnostic COVID-19 testing need to be following the EUA guidelines provided to the manufacturer of the kits/reagent they are using. These include notifying the State Health Department that they are testing, informing the State Health department of all positive testing, providing both the ordering provider and the patient the FAQ's education pieces that each manufacturer distributes once the EUA is approved. Providers may be submitting requisitions with signs and symptoms, as outlined in the AHA coding clinic attached above. At this time there are no payers, including CMS that have established diagnosis code edits specific to U0002 or 87635.
One caution.. since clinical laboratories during this pandemic are essentially acting as public health laboratories it is essential in order to appropriately communicate results that a direct provider to laboratory arrangment occur.. meaning the laboratory that is rendering the test needs to be the one billing it in all possible scenarios. The EUA letters are specific that ALL data specific to this testing be held and stored until told by the FDA that it does not need to be. Meaning longer than 2 years per CLIA, and potentially longer than state law specific to medical record retention. Laboratories should expect potential delays in reimbursement, as well as payer policies requiring additional information on claim forms that could include the name of the test that the lab is performing, and the manufacturer. If you are a hospital and are using a reference laboratory to perform the test but you are billing for it. Disclose the laboratory as the service provider, and append the 90 modifier on the CPT code. Refer to your payer on inpatient guidelines.
All of the kits/reagents and Laboratory Developed Tests Authorized by the FDA as of 4/8/2020- if you are not using one of these, or developed your own and received a letter from the FDA authorizing- probably shouldn't be testing......
Example of the LabCorp Fact Sheet for Patients
Example of the Quest Fact Sheet for Healthcare Providers
Hope this helps, probably more than you were looking for, but these are the most frequent questions I am responding to from my clients both that are clinical laboratories and commercial payers.
