When billed to health plans or the government

Test Name Description CPT/HCPC Codesa Price Case Price/Cost
SARS-CoV-2 RNA (COVID-19), Qualitative NAAT The test is designed to detect the virus that causes COVID-19 in respiratory specimens, for example, nasal or oral swabs. 87635 Mainstream Diagnostic Laboratory will bill your health plan or the government $300.00 or $450.00 depending on the plan Zero out-of-pocket patient responsibility is expected for medically appropriate testing ordered by an authorized provider when billed to a health plan or the government
SARS-CoV-2 Serology (COVID-19) Antibodies (IgG, IgM) The test is designed to detect IgG and IgM antibodies in a blood sample that may indicate exposure to COVID-19. IgM antibodies to COVID-19 are generally detectable in blood several days after initial infection, with IgG antibodies typically reaching detectable levels simultaneously or 1-2 days later.

86769 x2

Mainstream Diagnostic Laboratory will bill your health plan $110.00c Zero out-of-pocket patient responsibility is expected for medically appropriate testing ordered by an authorized provider when billed to a health plan or the government

When patient pays out-of-pocket through Mainstream Diagnostic Laboratory

Test Name
Description CPT/HCPCS Codesa Price* Cash Price/Cost
COVID-19 NAAT The test is designed to detect the virus that causes COVID-19 in respiratory specimens. This test is for individuals who decide to pay out-of-pocket for the test and do not wish to have their claims submitted for reimbursement to their health plan or the government. NA Total Patient Cash Price/Cost: $155.00*

 

 

*Pricing is comprised of $149.00 for testing and conveyance of results, plus $6.00 for electronic order review by an authorized third-party provider
$155.00
COVID-19 IgG/IgM Antibody Test The test is designed to detect antibodies in a blood sample that would indicate that a patient may have had a prior or recent COVID-19 infection. This test is for individuals who decide to pay out-of-pocket for the test and do not wish to have their claims submitted for reimbursement to their health plan or the government. NA Total Patient Cash Price/Cost: $75.00*

 

 

*Pricing is comprised of $69.00 for testing and conveyance of results, plus $6.00 for independent physician oversight of lab testing including ordering testing if appropriate, and providing physician follow-up services
$75.00

a The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

c The amount the Payer pays may vary based on coverage and contracted rates.

 

COVID-19 testing statements

  • The antibody tests, molecular tests, and antigen tests have not been FDA cleared or approved;
  • All tests have been authorized by FDA under EUAs for use by authorized laboratories;
  • The antibody tests have been authorized only for the detection of IgG and IgM antibodies against SARS-CoV-2, not for any other viruses or pathogens;
  • The COVID-19 NAAT tests have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens;
  • The antigen tests have been authorized only for the detection of proteins from SARS-CoV-2, and not for any other viruses or pathogens; and
  • All tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

 

About the FDA Emergency Use Authorization (EUA) Status

This test has been authorized by the FDA under an Emergency Use Authorization (EUA). This means that while Mainstream Diagnostic Laboratory has validated the test and has the data to believe the test and the collection kit are accurate, this test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by authorized laboratories; this test has been authorized only for the detection of IgG and IgM antibodies against SARS-CoV-2, not for any other viruses or pathogens; and, this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(B)(1) of the Act, 21 U.S.C. § 360BBB-3(B)(1), unless the authorization is terminated or revoked sooner. Additional studies need to be conducted for this test and others like it to be FDA cleared or approved.