The expert coding team at AIMA has compiled this comprehensive guide to help established and start-up independent laboratories. We have drawn together the latest information on COVID-19 testing into one centralized resource to save you time.
Throughout this essential guide, we will cover;
- Coronavirus COVID-19 testing definitions, types, and methods
- Who can test for COVID-19?
- Who can order a COVID-19 test?
- Which reporting codes to use for a COVID-19 test
- Which HCPCS/CPT codes to use and reimbursement rates with specific details for:
- HCPCS Codes for Specimen Collection for COVID-19 Testing
- HCPCS Codes for COVID-19 RT-PCR Testing
- CPT Codes for COVID-19 Antibody Testing
- CPT Code for Antigen Testing
- PLA Codes for COVID-19 Antibody Testing
- Who should be tested for COVID-19?
“AIMA is massively helping us to scale up our COVID testing operations, effectively overnight. With their help, we can enter and audit the demographic data from 10,000 requisition forms into our LIS each day. They are extremely flexible to unpredictable demand and have adapted to our processes very quickly. They are our chosen billing partner, so we know what they bring to the table and trust them to get it right. We would highly recommend their data entry services.”
Mid-Atlantic laboratory
Clinical laboratories stand at the forefront of fighting the spread of coronavirus COVID-19 and, especially, independent laboratories.
It is fair to say; independent laboratories have been at the less favorable end of ongoing government reforms. Margins have thinned and growth threatened by the expansion of the big network labs such as Quest and Labcorp. So much to say, many have been dying a slow death. However, in the face of this pandemic, their role has been vital. While the big network labs struggled to turnaround results in a timely fashion, independent labs have appeared like knights in shining armor. Agile and reactive, providing results in 24 – 48 hours, helping communities to stay safe and the economy to move forward.
AIMA has successful partnerships with independent laboratories across the country. We offer:
- Expert guidance and support on new testing lines, reimbursement rates, forecasting and the development of sustainable business objectives.
- Continuously back their quest to meet maximum test volumes in minimum timeframes.
- Provide essential back-office solutions to enable mass processing of patient data entry. Our robust infrastructure can handle any volume requirement from 100s to 10,000s and more per day.
- Facilitate the development of financial and networking strategies to ensure accurate, first-time coding and reimbursement.
The following first-hand observations and up-to-date guidance will help independent labs to navigate the various testing options and reimbursement models for maximum value.
For more detailed information, please contact the AIMA team today. We are here to help and support US laboratories with our expert business consultancy, coding and reimbursement solutions.
TESTING METHODS
To begin, we look at the two different types of tests – diagnostic and antibody.
A diagnostic test can show if the patient has an active COVID-19 infection and if the patient should take steps to quarantine or isolate themself from others. Currently, there are two types of diagnostic tests which can detect the virus. Firstly, molecular tests, for instance, RT-PCR tests, that identify the virus genetic material. Secondly, antigen tests detect specific proteins on the virus—the common administration of samples for both tests is via a nasal swab.
An antibody test identifies IgG and IgM antibodies synthesized by the human immune system in response to a threat, such as a virus. Antibodies help the body fight infections. Antibodies can take several days to develop after an infection has occurred and may stay in the blood for several weeks or more after recovery. Due to this reason, antibody tests are ineffective in the diagnosis of active coronavirus infection. The administration of an antibody test sample is mostly via a blood draw.
TYPES OF CORONAVIRUS COVID-19 TESTS
| Molecular Test (RT-PCR) | Antigen Test | Antibody Test | |
| Also known as | Diagnostic test, viral test, molecular test, nucleic acid amplification test (NAAT), RT-PCR test, LAMP test, real-time polymerase chain reaction. | Rapid test (Some molecular tests are also rapid tests). | Serological test, serology, blood test, serology test, IgG, IgM, strip test. |
| How is the sample taken? | Nasal or throat swab or saliva. | Nasal or throat swab. | Fingerstick or blood draw. |
| How long does it take to get results? | Same-day or up to a week. | 1 hour or less. | Same-day or 1-3 days. |
| Is another test needed? | There is a high level of accuracy. No further testing required. | Positive results are highly accurate. However, a further molecular test is required to confirm a negative result. | Accurate results may be reliant on subsequent tests. |
| What does it show? | Diagnosis of active COVID-19 infection. | Diagnosis of active COVID-19 infection. | Confirmation of past COVID-19 infection. |
| What can’t it do? | It cannot show if the patient ever had or was infected with the COVID-19 infection in the past. | Compared to molecular tests, antigen tests have a high likelihood of missing an active COVID-19 infection. Physicians may order a RT-PCR test if the antigen test returns negative, but the patient still presents symptoms of coronavirus. | Diagnose active COVID-19 infection at the time of the test or show that the patient does not have coronavirus. |
Other Types of Tests
- Rapid, POC diagnostic tests use a mucus sample from the nose or throat. Analysis of samples at the doctor’s office or clinic where the specimen was collected and results available in minutes. These may be molecular or antigen tests.
- At-home collection tests allow the patient to take the sample at home and send it directly to the lab for analysis.
- Saliva tests allow a patient to spit into a tube rather than get their nose or throat swabbed. Saliva tests may be more comfortable for some people and maybe safer for health care workers who can be farther away during the sample collection.
WHO CAN TEST FOR COVID-19?
The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 260,000 laboratory entities. CLIA registered laboratories with a CLIA of Registration and Accreditation can test for COVID-19 using RT-PCR equipment with high-throughput capabilities
The FDA publishes a list of all tests under their Emergency Use Authorization (EUA) for COVID-19. Specifically, within the Test Kit Manufacturers and Commercial Laboratories table, it states “patient care settings outside of the clinical laboratory environment,” “near-patient testing,” or “point of care,” the EUA can be used by CLIA waived laboratories. Such facilities must report either U0002 or 87635 with a -QW modifier.
The FDA issued revised guidance on March 16, 2020, which offers two different options for accelerating the development of specific laboratory tests for COVID-19.
- Option One – Laboratories can pursue EUA from the FDA as described in the FDA guidance released on February 29, 2020 (and any subsequent revisions). Testing can be performed upon completion of validation even before the laboratory receives FDA EUA. The FDA recommends submitting a EUA request within 15 days after completing the validation.
- The second option allows state authorization of high-complexity, CLIA-certified laboratories to perform tests developed and validated for COVID-19 within their state. States which choose to authorize laboratories to develop and perform a test for COVID-19 do so under the authority of its state law. Labs developing tests following this path engage directly with the appropriate state authorities, instead of with the FDA. These laboratories are not required to pursue EUA with the FDA.
The revised FDA guidance also includes new information for commercial manufacturers to expand the nation’s capacity for COVID-19 testing during the public health emergency. Under certain conditions, there will be no objections to commercial manufacturers developing and distributing COVID-19 test kits after completion of the manufacturer’s validation of the test for specimen testing before the FDA granting EUA status. The FDA considers 15 days a reasonable period to prepare and submit a EUA request.
Here is a link to a list of manufacturers who are EUA approved by FDA for COVID-19 testing.
WHO CAN ORDER A COVID-19 TEST?
For the duration of the Public Health Emergency for the COVID-19 pandemic, CMS has amended several rules. For instance, those relating to a treating physician or non-physician practitioner ordering specific clinical diagnostic laboratory tests. Now under state law, any healthcare professional can order COVID-19 diagnostic laboratory tests (including serological and antibody tests). Since the similarities in symptoms for coronavirus, influenza, and respiratory syncytial virus (RSV), there is justification for concurrent testing for all three infections. The interim policy also applies to influenza and RSV tests, but only in conjunction with a medically necessary COVID-19 diagnostic laboratory test. The aim is to establish or rule out a COVID-19 diagnosis or identify an adaptive immune response to SARS-COV-2.
WHICH REPORTING CODES TO USE FOR A COVID-19 TEST
The Centers for Disease Control and Prevention (CDC) published its ICD 10 CODES to report COVID-19 exposure:
Z03.818 – Encounter for observation for suspected exposure to other biological agents ruled out (possible exposure to COVID-19)
Z11.59 – Encounter for screening for other viral diseases (asymptomatic)
Z20.828 – Contact with and (suspected) exposure to other viral communicable (confirmed exposure to COVID-19)
Providers can also add diagnosis codes related to symptoms of upper respiratory infection if available, for example:
R05: Cough
R06.02: Shortness of breath
R50.9: Fever, unspecified
J12.89: Other viral pneumonia
J20.8: Acute bronchitis due to other specified organisms
J22: Unspecified acute lower respiratory infection
J40: Bronchitis, nor specified as acute or chronic
J80: Acute respiratory distress syndrome
J96.01: Acute respiratory failure with hypoxia
J98.8: Other specified respiratory disorders
WHICH HCPCS/CPT CODES TO USE AND REIMBURSEMENT RATES
The Centers for Medicare and Medicaid (CMS) developed the Healthcare Common Procedure Coding System (HCPCS). The American Medical Association (AMA) developed the Current Procedural Terminology (CPT). Laboratories use both systems to report medical procedures and services.
HCPCS Codes for Specimen Collection for COVID-19 Testing
The Centers for Medicare and Medicaid Services (CMS) established the following HCPCS codes to identify and reimburse specimen collection for COVID-19 testing effective on March 1, 2020:
- G2023 Specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), any specimen source
- G2024 Specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), from an individual in a skilled nursing facility or by a laboratory on behalf of a home health agency, any specimen source
Only clinical diagnostic laboratories may report these codes. Labs should use G2023 to report specimens collected from homebound patients and HCPCS G2024 to report samples collected from patients in skilled nursing facilities or on behalf of home health agencies. Medicare pays $25.46 for either G2023 or G2024.
HCPCS Codes for COVID-19 RT-PCR Testing
The CMS also established the following new HCPCS codes for COVID-19 tests in early March 2020:
- U0001 CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel
- U0002 2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC
Providers should only report HCPCS code U0001 if the CDC assay is performed.
On March 12, 2020, the CMS announced the following Medicare reimbursement amounts for these codes:
- U0001: $35.91
- U0002: $51.31
The CMS has also created the following HCPCS codes for the detection of SARS–CoV–2 or the diagnosis of the virus that causes COVID-19, making use of high throughput technologies:
- U0003: Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique, making use of high throughput technologies as described by CMS-2020-01-R.
- U0004: 2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC, making use of high throughput technologies as described by CMS-2020-01-R.
The CMS defines high throughput technology, as testing that uses a platform to employ automated processing of more than two hundred specimens a day. Examples of high throughput technology include but are not limited to technologies such as the Roche Cobas 6800 System, Roche Cobas 8800 System, Abbott m2000 System, Hologic Panther Fusion System, GeneXpert Infinity System, and NeuMoDx 288 Molecular.
Medicare currently reimburses $100.00 for U0003 and U0004. These codes may not be used to report antibody tests.
CPT Codes for COVID-19 Antibody Testing
The American Medical Association AMA CPT Editorial Panel convened a second special meeting on April 10, 2020, to approve the following codes specific for reporting COVID-19 serology testing.
- 86328 Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single-step method (e.g., reagent strip); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19])
- 86769 Antibody; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19])
CPT code 86328 should be reported once for each reagent strip assay. If the reagent strip tests for one or multiple antibody classes (for example, IgG and IgM), report one unit of service, regardless of the number of antibody immunoglobulin classes evaluated and reported on the reagent strip.
On the other hand, if multiple assays are performed for antibodies of different immunoglobulin classes, use a multistep laboratory method. Report each assay separately using CPT code 86769. Append Modifier -59 to the code reported for the second assay to identify the performance of two distinct analyses.
Current Medicare reimbursement for the antibody testing codes is as follows:
- 86328: $45.23
- 86769: $42.13
CPT Code for Antigen Testing
More recently, on June 26, 2020, the AMA approved the following additional code for COVID-19 antigen testing by immunoassay techniques:
- 87426 Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; severe acute respiratory syndrome coronavirus (e.g., SARS-CoV, SARS- CoV-2 [COVID-19])
This code is currently contractor priced. Final payment will probably be similar to 87635 above; however, laboratory associations have argued for a $100.00 fee identical to the high throughput assays described below.
PLA Codes for COVID-19 Antibody Testing
The following PLA code has also been approved and will be priced on the 2021 Medicare Clinical Laboratory Fee Schedule, probably the same as CPT code 87633 (respiratory virus panel, 12-25 targets) at $416.78.
- 0223U Infectious disease (bacterial or viral respiratory tract infection), pathogen-specific nucleic acid (DNA or RNA), 22 targets including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), qualitative RT-PCR, nasopharyngeal swab, each pathogen reported as detected or not detected
Providers may use PLA code 0223U only when the performance of the testing
using the QIAstat-Dx Respiratory SARS-CoV-2 Panel, from QIAGEN Sciences, QIAGEN GMbHb.
The AMA has also issued the following PLA code for COVID-19 antibodies:
- 0224U antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), includes titer(s) when performed
This code may is only to be used to report the performance of the COVID-19 Antibody Test by Mount Sinai Laboratory. Medicare has yet to establish a reimbursement amount for 0224U.
WHO SHOULD BE TESTED FOR COVID-19?
CDC Mitigation Protocols (As of September 4, 2020)
CDC recommends the following measures to mitigate the spread of the virus and to protect vulnerable populations: social distancing, wearing a mask when social distancing is not possible, avoiding crowds, avoiding crowded indoor spaces, and washing or sanitizing hands frequently. Visit cdc.gov/coronavirus for more information.
Considerations for COVID-19 Diagnostic (Molecular or Antigen) Testing
- If you have symptoms of COVID-19:
- If your symptoms are mild:
- Your health care provider (physician, nurse practitioner, pharmacist, etc.) may advise a COVID-19 test.
- If you test positive for COVID-19 or do not get tested, you should self-isolate for at least 10 days after symptom onset and at least 24 hours after the resolution of any fever (without the use of fever-reducing medications).
- You should strictly adhere to CDC mitigation protocols in circumstances in which you cannot self-isolate, especially if you are interacting with a vulnerable individual (for example an elderly person or an individual with an underlying health condition). You should adhere to CDC guidelines to protect vulnerable individuals with whom you live.
- If you live with a vulnerable individual, they should be tested.
- If your symptoms are severe or become severe, you should contact your health care provider immediately or seek emergency care.
- If you take a test and test positive, you do not need to repeat a test. Unless your illness required hospitalization, you can return to normal activities (e.g., work or school) after the passage of 10 days from the onset of symptoms and 24 hours from when any fever has subsided on its own (without the aid of any fever-reducing medications).
- If your symptoms are mild:
- If you have been in close contact (within 6 feet) of a person with a COVID-19 infection for at least 15 minutes but do not have symptoms:
- You do not necessarily need a test unless you are a vulnerable individual or your health care provider or State or local public health officials recommend you take one.
- A negative test does not mean you will not develop an infection from the close contact or contract an infection at a later time.
- You should monitor yourself for symptoms. If you develop symptoms, you should evaluate yourself under the considerations set forth above.
- You should strictly adhere to CDC mitigation protocols, especially if you are interacting with a vulnerable individual. You should adhere to CDC guidelines to protect vulnerable individuals with whom you live.
- You do not necessarily need a test unless you are a vulnerable individual or your health care provider or State or local public health officials recommend you take one.
- If you do not have COVID-19 symptoms and have not been in close contact with someone known to have a COVID-19 infection:
- You do not need a test.
- A negative test does not mean you will not contract an infection at a later time.
- If you decide to be tested, you should self-isolate at home until your test results are known, and then adhere to your health care provider’s advice. This does not apply to routine screening or surveillance testing at work, school, or similar situations.
- You do not need a test.
- If you are in a high COVID-19 transmission area and have attended a public or private gathering of more than 10 people (without widespread mask wearing or physical distancing):
- You do not necessarily need a test unless you are a vulnerable individual or your health care provider or State or local public health officials recommend you take one.
- A negative test does not mean you will not develop an infection from the gathering or contract an infection at a later time.
- You should monitor yourself for symptoms. If you develop symptoms, you should evaluate yourself under the considerations set forth above.
- You should strictly adhere to CDC mitigation protocols, especially if you are interacting with a vulnerable individual. You should adhere to CDC guidelines to protect vulnerable individuals with whom you live.
- If you are tested, you should self-isolate at home until your test results are known, and then adhere to your health care provider’s advice.
- You do not necessarily need a test unless you are a vulnerable individual or your health care provider or State or local public health officials recommend you take one.
- If you work in a nursing home or a long-term care facility:
- You will need to be tested, unless you have already been tested as part of your facility’s operational plans.
- You need to be tested if you are symptomatic. You must not go to work until your test results are known. If you test positive, unless your illness required hospitalization, you can return to work after the passage of 10 days from the onset of symptoms and 24 hours from when any fever has subsided on its own (without the aid of any fever-reducing medications).
- You will need testing if there is an outbreak in your facility (i.e., a new COVID-19 infection in any staff or any nursing home-onset of COVID-19 in a resident), and you will need to be tested at regular intervals until the outbreak has been mitigated.
- The higher the incidence rate in the county in which you live or work, the more frequently you will need to be tested.
- Results of testing will be used to inform infection control interventions at your facility, including decisions regarding resident placement and work exclusions.
- Follow any additional guidance from State and local public health officials and the Centers for Medicare and Medicaid Services (CMS).
- If you live in or receive care in a nursing home or a long-term care facility:
- You will need to be tested unless you have already been tested as part of your facility’s operational plans.
- You need to be tested if you are symptomatic. You must self-isolate until your test results are known. If you test positive, unless your illness required hospitalization, you can return to normal activities after the passage of 10 days from the onset of symptoms and 24 hours from when any fever has subsided on its own (without the aid of any fever-reducing medications).
- You will need testing if there is an outbreak in your facility, and you will need to be tested at regular intervals until the outbreak has been mitigated.
- You will need to be tested more frequently if you leave the facility on a regular basis (e.g. for dialysis or frequent medical/other appointments).
- Results of testing will be used to inform infection control interventions at your facility, including decisions regarding resident and patient placement.
- Follow any additional guidance from State and local public health officials and the CMS.
- If you are a critical infrastructure worker, health care worker, or first responder:
- You may need to get a test, according to your employer’s guidelines.
- Even if you have a negative test, you should, at all times, take special care to monitor yourself for symptoms and strictly adhere to CDC mitigation protocols.
- State and local public health officials may advise specific people, or groups of people, to be tested. You should follow this advice.
- It is important to realize that you can be infected and spread the virus but feel well and have no symptoms.
- In areas where there are limited number of new cases, State or local public health officials may request to test a small number of asymptomatic “healthy people,” particularly from vulnerable populations.
- If there is significant spread of the virus in your community, State or local public health officials may request to test more asymptomatic “healthy people,” particularly from vulnerable populations.
- For example, certain settings can experience rapid spread of COVID-19. This is particularly true for settings with vulnerable populations in close quarters for extended periods of time (e.g., hospitals, nursing homes, and long-term care facilities).
As discussed above, those responsible for managing infection in such settings should adopt measures to facilitate the early identification of infected individuals, including initial testing of everyone in the setting, periodic (e.g., weekly) testing of everyone in the setting and testing of new or returning entrants into the setting.