COVID-19 Laboratory Billing Information - Archives

1/15/2021 - What CPT codes should be used for COVID-19 testing? (posted 1/15/21). Aetna is complying with the CMS coding guidelines for COVID-19 lab testing? READ MORE 

11/30/2020 - Aetna is complying with the CMS coding guidelines for COVID-19 lab testing. The following codes should be used for COVID-19 testing for commercial and Medicare plans: U0001, U0002, U0003, U0004, 0202U, 0223U, 0225U, 0226U, 0240U, 0241U, 86413, 87426, 87635, 87636, 87637, 87811, 86328, 86408, 86409, 86769, 99000, 99001 & 0224U. READ MORE

7/10/2020 - COVID-19 Billing & Coding Updates:  Aetna is complying with the CMS coding guidelines for COVID-19 lab testing. CMS adopted four CPT codes, (U0001), (U0002), (U0003) and (U0004) for COVID-19 diagnostic testing. Aetna will accept CPT code 87635 or HCPCS Level II U0002 for the COVID-19 diagnostic testing.   The following codes should be used for COVID-19 testing for commercial and Medicare plans: U0001 - U0004, 87635, 87426, 0223U, 86328, 86769 and 0224U. READ MORE

6/19/2020 - COVID-19 Testing Updates. READ MORE 

5/19/2020 - Aetna is complying with the CMS coding guidelines for COVID-19 lab testing. CMS adopted four CPT codes (U0001),(U0002),(U0003) and (U0004) for COVID-19 diagnostic testing. READ MORE

Aetna will reimburse contracted and non-contracted providers for COVID-19 testing as follows in accordance with the member's benefit plan: (U0001) - $35.91; (U0002) -$51.31; (U0003) - $100; (U0004) - $100; (87635) - $51.31; (99000) - $7; (99001) - $13 per test. Antibody testing rates for 86238 and 86769 are pending CMS guidance. READ MORE

4/6/2020 - Aetna is waiving member cost-sharing for diagnostic testing related to COVID-19. READ MORE

Aetna members cannot go directly to draw stations. Quest and LabCorp will not collect specimens for the test.
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2/26/2021 - ACLA Statement on President Biden’s Actions to Close Coverage Gaps for COVID-19 Testing. READ MORE 

7/14/2020 - ACLA Update on PCR Testing Capacity for COVID-19. READ MORE

6/27/2020 - ACLA Update on COVID-19 Testing Capacity. READ MORE 

6/23/2020 - ACLA Responds to New Tri-Agency Guidance, Calls on Federal Government to Address Newly-Created Coverage Gaps. READ MORE

6/15/2020 - Letter from the ACLA to the Director of the CDC regarding the CDC's 5/27/2020 guidance "Interim Guidelines for COVID-19 Antibody Testing." READ MORE

6/14/2020 - COVID-19 Response Efforts: Role of Commercial Laboratories. READ MORE

6/8/2020 - Amid Growing Demand for Testing, Lawmakers Call on HHS to Designate Resources for Clinical Laboratories. READ MORE

6/1/2020 - ACLA members have developed and validated novel COVID-19 tests and continue to scale up testing capacity. Members currently performing diagnostic tests for COVID-19 include Aculabs, Aegis Sciences, ARUP, Biodesix, BioReference Laboratories, Exact Sciences, Inform Diagnostics, LabCorp, Mayo Clinic Laboratories, NeoGenomics Laboratories, Quest Diagnostics and Sonic Healthcare. READ MORE

4/24/2020 - Anthem and its delegated entities will reimburse health care providers according to contract or other standard reimbursement rates, depending on provider participation and benefit plan for drive-thru COVID-19 testing. Anthem and its delegated entities will recognize the codes 87635 and U0002, and will reimburse drive thru COVID-19 tests according to the applicable lab fee schedule inclusive of member cost-share amounts. READ MORE

4/17/2020 - Anthem and its delegated entities will reimburse health care providers according to contract or other standard reimbursement rates, depending on provider participation and benefit plan. Payer recognizes codes 87635 and U0002, and will reimburse drive thru COVID-19 tests according to the applicable lab fee schedule inclusive of member cost-share amounts. READ MORE

Anthem Colorado, Indiana, Kentucky, Missouri, Ohio, Wisconsin

4/22/20  - Payer is encouraging providers to bill with codes U0001, U0002, U0003, U0004, 86328, 86769, or 87635 based on the test provided. READ MORE 

5/21/2020 - Updated the “Laboratory Testing” section of our COVID-19 Coding Guide to include the following: in-network fee amounts added for testing and specimen collection codes. READ MORE

5/20/2020 - Updated the “Laboratory Testing” section of our COVID-19 Coding Guide to include the following codes: "Specimen collection code added: C9803." BCBS Alabama is working with providers to ensure access to affordable care during this crisis. We encourage out-of-network providers to accept our payment for COVID-19 testing as payment in full and work together with us to protect our members from financial harm. READ MORE

5/12/2020 - Coronavirus Codes Added to List of Services Carved Out of EAPG Pricing. The "Services Carved Out of EAPG Pricing" document has been updated with three coronavirus HCPCS codes and their corresponding fees. (Provider portal access is required to follow the link). The newly added codes are G2023 ($23.46, eff 3-1-20), U0003 ($100, eff 4-14-20), and U0004 ($100, eff 4-14-20). READ MORE

4/28/2020 - Payer has updated the “Laboratory Testing” section of their COVID-19 Coding Guide to include the following codes. READ MORE

4/14/2020 - Payer has updated the “Laboratory Testing” section of their COVID-19 Coding Guide to include the following codes. READ MORE

4/3/2020 - Serologic antibody testing specific for COVID-19 can reveal if a patient has been exposed to the virus and had an immune response to the virus; however, it will not reveal if the patient is currently infected.  READ MORE

3/25/2020 - Code U0001-To be used to bill for CDC 2019 novel coronavirus (2019-ncov) real-time rt-pcr diagnostic panel. READ MORE

4/29/2020 - Payer is including in their payment policy U0003 and U0004 for dates of service on or after April 14, 2020. READ MORE

3/24/2020 - Effective with dates of service February 4, 2020, claims for COVID-19 tests for commercial, and Medicare Advantage members use CPT codes U0001, U0002 and 87635. Use ICD-10 codes (for patients presenting for evaluation of possible COVID-19) Z20.828, Z03.818 and Z11.59 and ICD-10 codes (if your patient has a previously confirmed COVID-19 illness or tested positive for COVID-19) B97.29, B97.21, U07.1 and B34.2. READ MORE

5/19/2021 - COVID-19: FAQs for Medicare Providers. READ MORE 

12/1/2020 - Additional COVID-19 Lab Code: 87428 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; severe acute respiratory syndrome coronavirus (eg, SARS-CoV, SARS-CoV-2 [COVID-19]) and influenza virus types A and B. READ MORE 

11/2/2020 - COVID-19 Antibody Testing Codes. READ MORE

7/27/2020 - Update to COVID-19 Lab Codes. READ MORE 

7/22/2020 - COVID-19 Provider Preparedness Updates. READ MORE 

6/12/2020 - Provider Information on COVID-19 coverage. READ MORE

5/29/2020 - FAQs with details on coverage for testing, testing-related visits and treatment Medicare Advantage and Medicare Supplement members won't pay copays, deductibles or coinsurance. READ MORE

5/19/2020 - Claims for COVID-19 Testing. READ MORE

5/4/2020 - The Employees Retirement System of Texas (ERS): Lab testing for COVID-19 is available to HealthSelect participants for both in-network and non-network labs at no member cost share. READ MORE

4/20/2020 - COVID-19 Lab Codes. Member cost-share will be waived if test is in accordance with medical standards. READ MORE

3/23/2020 - Covering testing to diagnose the 2019 COVID-19 for most members with no prior auth and no member cost share. READ MORE

11/24/2020 - COVID-19 Virus and Antibody Testing (updates dated 11/24/20). COVID-19 Viral and Serologic (Antibody) Testing. READ MORE 

8/7/2020 - Provider Letter 8/7/2020 - RE: COVID-19 Virus and Antibody Testing. READ MORE 

7/14/2020 - Updated COVID-19 Testing Guidance 7/14/2020.  This guidance is an update to the interim COVID-19 testing guidance issued by the California Department of Public Health (CDPH) on May 1, 2020. READ MORE

4/24/2020 - The State of California is not authorizing California laboratories to develop and perform tests for COVID-19 at this time and currently has not established a process for authorizing such tests. On February 29, 2020, the Food and Drug Administration (FDA) issued guidance with policy for diagnostic testing specific to COVID-19 and a source to apply for Emergency Use Authorization (EUA). Both of these resources are provided on this website. READ MORE

4/27/2021 - Advocacy Update 4/27/21. CAP Urges Passage of Bill to Eliminate Taxes on Provider Relief Funds.
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11/17/2020 - CAP Advocacy Update 11/17/20. ** CAP Members Call on Congress to Stop Medicare Cuts. READ MORE 

11/17/2020 - CAP Asks CMS to Reduce COVID-19 Laboratory Reporting Burdens, Increase Testing Resources.
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10/30/2020 - CAP Applauds Bipartisan House Bill Delaying Steep Medicare Cuts to Pathologists. READ MORE 

7/14/2020 - CAP Advocates to Address Testing Supply Shortages. READ MORE

3/9/2020 - Cover medically necessary diagnostic tests that are consistent with guidance from the Centers for Disease Control and Prevention (CDC) related to COVID-19 and waive the member's cost share (copay or coinsurance) for these tests.  Suspend the prior authorization requirement for diagnostic tests and for covered services that are medically necessary and consistent with CDC guidance for those diagnosed with COVID-19. READ MORE

5/21/2020 - Drug Testing: CareSource will temporarily no longer require a prior authorization for drug testing services rendered by qualified participating laboratories, even after the 30 presumptive/12 confirmatory annual member limit is reached. READ MORE

4/16/2020 - COVID-19: Temporary Expansion for Molecular Diagnostic Testing for Influenza Virus Infection and Streptococcus A and B, Effective 4/1/2020. READ MORE

7/27/22 - Lab Update FDA Updates FAQs on Testing for SARS-CoV-2. On July 26, 2022, the U.S. Food and Drug Administration (FDA) updated its FAQs on Testing for SARS-CoV-2 page to note that no tests remain on the commercial manufacturer serology test notification list described in FDA’s Policy for Coronavirus Disease-2019 Tests. All tests previously on the commercial manufacturer serology test notification list have either been issued an Emergency Use Authorization (EUA) or should no longer be distributed, marketed, or offered. READ MORE 

6/27/2022 - Lab Alert 6/27/22: FDA Revokes EUAs for Two SARS-CoV-2 Tests. READ MORE 

5/16/2022 - Lab Advisory 5/16/22: HHS to Discontinue Providing Viral Transport Media to States and Jurisdictions. READ MORE

5/12/2022 - Lab Update 5/12/22: Join the Next Clinical Laboratory COVID-19 Response Call on Monday, June 27th. READ MORE 

5/11/2022 - Lab Alert 5/11/22: Do Not Use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold). READ MORE 

5/3/2022 - Lab Alert 5/3/22: Counterfeit COVID-19 Self-Tests. The U.S. Food and Drug Administration (FDA) has recently published a website about counterfeit COVID-19 self-tests. READ MORE

5/2/2022 - Lab Alert 5/2/22: Celltrion USA Recalls Certain Point-of-Care DiaTrust COVID-19 Ag Rapid Test Kits. READ MORE 

4/20/2022 - Lab Update 4/20/2022. The Clinical Laboratory COVID-19 Response Calls take place on the third Monday of each month and are scheduled for one hour. The next call is scheduled for Monday, May 16.
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3/31/2022 - Lab Update 3/31/22. The U.S. Centers for Disease Control and Prevention (CDC) will host a virtual meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC) on April 13 and 14, 2022 from 11:00 AM to 6:00 PM EDT each day. READ MORE

3/24/2022 - Lab Alert 3/24/22. On February 8, 2022, BioRad issued a voluntary recall for the RPR portion of the BioPlex 2200 Syphilis Total & RPR Test Kit. The U.S. Food and Drug Administration (FDA) classified this as a Class 2 Device Recall on March 16, 2022. READ MORE 

3/22/2022 - Lab Advisory 3/22/22: Upcoming Schedule Changes for Clinical Laboratory COVID-19 Response Calls. READ MORE 

3/21/2022 - Lab Alert 3/21/22: FDA Recalls Specific Lot Numbers of Celltrion DiaTrust™ COVID-19 Ag Rapid Test. READ MORE 

3/2/2022 - Lab Advisory 3/10/22. HHS Updates COVID-19 Laboratory Reporting Guidance. On March 8, 2022, the U.S. Department of Health and Human Services (HHS) updated its Laboratory Data Reporting Guidance.
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3/2/2022 - Lab Alert 3/2/22. FDA Says Do Not Use These Unauthorized COVID-19 Tests. READ MORE 

1/28/2022 - Lab Updates 1/28/22: CDC Updates LOINC In Vitro Diagnostic (LIVD) Test Code Mapping Tool for SARS-CoV-2 Tests. Audience: Individuals Performing COVID-19 Testing. READ MORE 

1/13/2022 - Lab Alert 1/13/22: Stop Using LuSys Laboratories COVID-19 Tests. READ MORE 

12/20/2021 - Lab Alert 12/20/21: Possible False RPR Reactivity with BioPlex 2200 Syphilis Total & RPR Test Kit. READ MORE 

12/3/2021 - Lab Alert 12/3/21: CDC Update on the SARS-CoV-2 Omicron Variant. READ MORE 

11/29/2021 - Lab Advisory 11/29/21: CMS Publishes New FAQ about CLIA and Over-the-Counter Home Testing. 
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11/17/2021 - Lab Advisory 11/17/21: FDA Updates COVID-19 Testing Policies. READ MORE 

11/17/2021 - Lab Update 11/17/21. Join the next Clinical Laboratory COVID-19 Response Call on Monday, December 13, 2021. READ MORE

10/21/2021 - Lab Alert 10/21/21. CDC Updates LOINC In Vitro Diagnostic (LIVD) Test Code Mapping Tool for SARS-CoV-2 Tests to Include SNOMED-CT Saliva Terms. READ MORE 

10/7/2021 - Lab Alert 10/7/21 - CDC Updates LOINC In Vitro Diagnostic (LIVD) Test Code Mapping Tool for SARS-CoV-2 Tests. READ MORE

10/4/2021 - Lab Alert: Ellume Issues Voluntary Recall of Specific Lots of Ellume COVID-19 Home Tests. READ MORE

9/22/2021 - Lab Advisory - CDC Updates SARS-CoV-2 Variant Classifications. READ MORE

9/17/2021 - Lab Alert: FDA Issues Letter about Potential False Positive Results with Abbott Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits. READ MORE 

9/2/2021 - Lab Advisory: Shortage of COVID-19 Rapid Tests May Increase Demand for Laboratory Testing. READ MORE 

8/18/2021 - Lab Advisory: SARS-CoV-2 Variant Classification Updates. READ MORE 

8/9/2021 - Lab Advisory -  SARS-CoV-2 Variant Classification Updates. READ MORE 

8/6/2021 - Join the next Clinical Laboratory COVID-19 Response Call on Monday, August 23 at 3:00 PM ET. READ MORE  

8/2/2021 - Lab Alert: Clarifications about the Retirement of the CDC 2019 Novel Coronavirus (2019-nCov) Real-Time RT-PCR Diagnostic Panel. READ MORE 

7/26/2021 - Lab Advisory 7/26/21. READ MORE 

7/20/2021 - Lab Advisory 7/20/21: SARS-CoV-2 Variant Classification Updates. READ MORE 

7/18/2021 - Lab Alert 7/18/21: FDA Revokes EUA for Curative SARS-CoV-2 Assay. READ MORE 

7/15/2021 - Lab Advisory 7/15/21: CDC Updates Pooling Guidance and Overview for Testing for SARS-CoV-2 Web Pages. READ MORE 

7/6/2021 - SARS-CoV-2 Variants AY.1 and AY.2 Now Aggregated with Delta Variant B.1.617.2 On July 6, 2021, CDC announced that SARS-CoV-2 variants AY.1 and AY.2 are now aggregated with Delta variant B.1.617.2. READ MORE 

7/6/2021 - Lab Alert: Magellan Diagnostics Recalls Several LeadCare Blood Lead Tests Due to Risk of Falsely Low Results. READ MORE 

6/29/2021 - Lab Update 6/29/21: SARS-CoV-2 Variant Classification Changes. On June 29, 2021, the U.S. Centers for Disease Control and Prevention (CDC) announced the following changes to the SARS-CoV-2 variant classifications.
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6/25/2021 - Lab Update 6/25/2021: CDC Publishes New Web page on Biological Risk Management for Point-of-Care Testing. READ MORE 

6/16/2021 - Lab Update 6/16/21: CDC Updates Guidance for Reporting SARS-CoV-2 Sequencing Results. READ MORE 

6/15/2021 - Lab Update 6/15/21: CDC Updates COVID-19 Biosafety Guidelines. READ MORE

6/15/21 - Lab Advisory: CDC Classifies SARS-CoV-2 Variant B.1.617.2 (Delta) a Variant of Concern. READ MORE

6/14/2021 - Lab Alert 6/14/21: Sodium Citrate Blood Specimen Collection Tubes in Short Supply. READ MORE

6/14/2021 - Lab Advisory 6/14/21: CDC Launches New COVID-19 Viral Testing Tool. READ MORE 

5/28/2021 - Lab Advisory 5/28/21: CDC Updates Testing Strategies for SARS-CoV-2 Web Page. READ MORE 

5/20/2021 - Lab Advisory 5/20/21: CDC Updates NAATs and Self-Testing Web Pages. READ MORE

5/18/2021 - Lab Advisory 5/18/21: CDC Updates Interim Guidance for Antigen Testing for SARS-CoV-2. READ MORE 

5/5/2021 - Lab Advisory 5/5/21. SARS-CoV-2 Variants B.1.617, B.1.617.1, B.1.617.2, and B.1.617.3 Classified as Variants of Interest. READ MORE 

4/22/2021 - Lab Advisory: CDC Classifies SARS-CoV-2 Variant B.1.526.1 a Variant of Interest. READ MORE 

4/9/2021 - Lab Advisory: New Guidance for Reporting SARS-CoV-2 Sequencing Results. READ MORE 

3/31/2021 - Lab Advisory: FDA Publishes New Web Page on Impact of SARS-CoV-2 Viral Mutations on COVID-19 Molecular Tests. READ MORE 

3/26/2021 - Lab Advisory: CDC Publishes New Web Page on Nucleic Acid Amplification Tests (NAATs). READ MORE 

3/22/2021 - Lab Update. CMS Posts FAQ for Reporting Sequencing Results for SARS-CoV-2 Variants. READ MORE

3/13/2021 - Lab Alert. On March 12, 2021, the U.S. Food and Drug Administration (FDA) issued a Letter to Clinical Laboratory Staff, Point-of-Care Staff, and Health Care Providers about false positive results that can occur with the Roche Molecular Systems, Inc. cobas SARS-CoV-2 and Influenza A/B Nucleic Acid Test used on the cobas Liat System.
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3/2/2021 - Lab Advisory: FDA Issues New Guidance for Evaluating Impact of Viral Mutations on COVID-19 Tests.
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2/27/21 - Lab Update: CDC Updates Interim Guidelines for Collecting and Handling Clinical Specimens for COVID-19 Testing. READ MORE 

2/23/2021 - Lab Update: COVID-19 Science Update. READ MORE 

2/2/2021 - Lab Advisory 2/2/21. On January 31, 2021, CDC published new web pages on Genomic Surveillance for SARS-CoV-2 Variants. READ MORE 

1/13/2021 - Lab Advisory 1/13/2021. CMS Updates CLIA Surveyor Guidance for SARS-CoV-2 Test Result Reporting.
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1/13/2021 - FDA Updates Reporting Guidance, Authorizes Update to IFU for CDC Influenza SARS-CoV-2 Multiplex Assay. READ MORE 

1/6/2021 - Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with COVID-19. READ MORE 

12/28/2020 - Lab update 12/28/20. CDC Offers new Infographics for SARS-CoV-2 Point-of-Care Tests. READ MORE 

12/19/20 - Lab Update - CMS Updates FAQs for CLIA Guidance during the COVID-19 Public Health Emergency.
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12/7/2020 - On Monday December 7, 2020, the CMS updated the frequently asked questions (FAQs) to include revised Clinical Laboratory Improvement Amendments (CLIA) enforcement discretion guidance during the COVID-19 public health emergency. READ MORE 

12/5/2020 - CDC updated the Interim Guidance for Antigen Testing for SARS-CoV-2 Web page. READ MORE 

12/3/2020 - Lab Update 12/3/20. CDC Offers new COVID-19 Specimen Collection Infographics. READ MORE 

11/30/2020 - New from CDC - Job Aids for Laboratory Professionals. READ MORE 

11/30/2020 - Guidance for SARS-CoV-2 Point-of-Care Testing. READ MORE 

11/30/2020 - ONGOING: Biweekly Clinical Laboratory COVID-19 Response Calls. READ MORE

11/17/2020 - CDC recently updated the Frequently Asked Questions (FAQ's) about COVID-19 for Laboratories to include new information on cycle threshold (Ct) values for reverse transcriptase-polymerase chain reaction (RT-PCR) tests for SARS-CoV-2. READ MORE 

11/3/2020 - On November 3, 2020, CDC updated the Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with COVID-19 web page. READ MORE 

10/23/2020 - CDC's CLIAC Upcoming Meeting Calendar. READ MORE 

10/17/2020 - On Monday, October 13, the FDA issued and immediately implemented a new guidance: Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. READ MORE 

10/12/2020 - The US Department of Health and Human Services (HHS) recently announced that the FDA will not require premarket review of Laboratory-Developed Tests (LDTs) for SARS-CoV-2. READ MORE 

10/5/2020 - Lab Advisory: Guidance for LOINC In-Vitro Diagnostic Code Selection for Labs Using Laboratory-Developed Tests. READ MORE 

10/1/2020 - Lab Advisory 10/1/20 - CMS Releases New Laboratory Quick Start Guide for CMS CLIA Certification.
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10/1/2020 - CSTE Posts New Electronic Laboratory Reporting Points of Contact for COVID-19. READ MORE 

9/23/2020 - Lab Advisory 9/23/20: LOINC In-Vitro Diagnostic (LIVD) Codes for SARS-CoV-2 Antigen Tests. READ MORE 

9/3/2020 - CMS recently released new surveyor guidance for SARS-CoV-2 Laboratory Test Results Reporting for CLIA-certified laboratories. READ MORE 

8/29/2020 - Lab Update: CMS Publishes New CLIA Facts. READ MORE 

8/26/2020 - CMS Issues New Rule for SARS-CoV-2 Laboratory Test Result Reporting. READ MORE

8/18/2020 - Lab Alert: On August 17, 2020, the U.S. Food and Drug Administration (FDA) issued a safety letter about the Thermo Fisher Scientific TaqPath COVID-19 Combo Kit. READ MORE 

8/16/2020 - Lab Advisory on new COVID-19 Antigen Testing Guidance. READ MORE 

8/16/2020 - Report False Negatives and False Positives from COVID-19 Testing. READ MORE    

8/5/2020 - Lab Update: CDC Updates Reporting Facts for COVID-19 Testing. READ MORE

7/31/2020 - Lab Advisory: Update on COVID-19 Laboratory Reporting Requirements. READ MORE 

7/28/2020 - Lab Update: FDA Issues COVID-19 Testing and Policy Updates. READ MORE

7/24/2020 - Lab Advisory: CDC releases new test pooling guidance for SARS-CoV-2. READ MORE 

7/23/2020 - Lab Advisory: CDC Publishes 'Primers & Probes' for Research Use Only SARS-CoV-2 (Flu SC2) Multiplex Assay, a real-time RT-PCR test that detects and differentiates RNA from SARS-CoV-2, influenza A virus, and influenza B virus in upper or lower respiratory specimens. READ MORE

7/22/2020 - Lab Advisory: Update on Laboratory Reporting Guidance for SARS-CoV-2. READ MORE

7/18/2020 - Lab Advisory: FDA Amends Instructions for Use of CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel.
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7/9/2020 - Lab Advisory: CDC Multiplex Assay Receives Authorization from FDA. READ MORE

7/1/2020 -  Lab Alert: DOT Issues Safety Notice for Transportation of COVID-19 Diagnostic Samples. READ MORE

6/10/2020 - Clinical Laboratory COVID-19 Response Weekly Calls. READ MORE

6/19/2020 - CDC's Division of Laboratory Systems (DLS):  Clinical Laboratory COVID-19 Response Weekly Call on Monday, July 6 at 3:00 PM EDT. READ MORE

6/19/2020 - CDC's Division of Laboratory Systems (DLS):  Join the Next Clinical Laboratory COVID-19 Response Weekly Call on Monday, June 22 at 3:00 PM EDT. READ MORE

6/12/2020 - CDC updates Laboratory Biosafety Guidelines and Questions & Answers. READ MORE

5/22/2020 - CDC updated the COVID-19 transmission web page to clarify information about types of spread.
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5/7/2020 - On May 6, 2020, CDC posted an updated version of the LOINC In Vitro Diagnostic (LIVD) Test Code Mapping Tool for SARS-CoV-2 Test Results. READ MORE

4/9/2020- FDA Clarifies CLIA-waived Status for Point-of-Care SARS-CoV-2 Tests under Emergency Use Authorizations. READ MORE

3/17/2020 - Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19).  READ MORE

12/9/2021 - MLN Connects: Publications - Independent Diagnostic Testing Facility (IDTF) — Revised. READ MORE

6/9/2021 - MLN Matters: Healthcare Common Procedure Coding System (HCPCS) Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments (CLIA) Edits. READ MORE 

6/3/201 - MLN Connects 6/3/21. Clinical Diagnostic Laboratories and establishing payment amounts for new or substantially revised HCPCS codes. READ MORE

6/2/2021 - MLN Matters 6/2/21 - Healthcare Common Procedure Coding System (HCPCS) Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments (CLIA) Edits. READ MORE 

5/20/2021 - Quarterly Update for Clinical Laboratory Fee Schedule (CLFS) and Laboratory Services Subject to Reasonable Charge Payment. MLN Matters M12285, CR R10810CP. Effective Date 7/1/21 and Implementation Date 7/6/21.
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3/18/2021 - MLN Connects: Clinical Laboratory Data Reporting Delayed Until 2022. READ MORE   

3/9/2021 - MLN Matters 3/9/2021 MM12178 effective 4/1/21, implementation 4/5/2021. Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment. READ MORE 

3/9/2021 - MLN Matters 3/9/21 MM12140 effective 1/1/2021, implementation is no later than 3/19/21. Clinical Laboratory Fee Schedule – Medicare Travel Allowance Fees for Collection of Specimens. READ MORE 

1/20/2021 - MLN Matters 1/20/21 MM12131 effective 4/1/2021 Implementation 4/5/21. HCPCS Codes Subject to and Excluded from CLIA Edits. READ MORE

12/23/2020 - MLN Connects 12/23/20.  ICD-10 Code Files for FY 2021. READ MORE  

12/22/2020 - MLN Connects 12/22/20 Special Edition. COVID-19 Vaccine Codes: Updated Effective Date for Moderna. READ MORE

11/25/2020 - MLN Connects 11/25/20. ** Clinical Laboratory Fee Schedule: CY 2021 Final Payment Determinations. READ MORE 

10/15/2020 - CMS Press Release 10/15/20. CMS Changes Medicare Payment to Support Faster COVID-19 Diagnostic Testing. READ MORE 

10/15/2020 - CMS Takes Action to Protect Integrity of COVID-19 Testing. A recent record check by CMS resulted in the issuance of 171 cease and desist letters to facilities that did not have proper CLIA certifications in place. Every facility that conducts COVID-19 testing is considered a “laboratory” and must be certified under CLIA .READ MORE 

10/15/2020 - Starting 1/1/21, Medicare will pay $100 to Labs that complete the high throughput COVID-19 Diagnostic tests within two days and $75 if completed longer than two days. This policy is to ensure the patients who test positive for the virus are alerted quickly so they can self-isolate and receive medical treatment. READ MORE 

10/15/2020 - MLN Connects 10/15/20. CMS Takes Action to Protect Integrity of COVID-19 Testing. READ MORE 

10/9/2020 - CMS is taking every action to ensure US laboratories are fit to deliver reliable, accurate and timely patient test results for coronavirus disease 2019 (COVID-19) by confirming Clinical Laboratory Improvement Amendments of 1988 (CLIA) certifications are up-to-date. READ MORE 

9/25/2020 - CMS Releases New Tools to Streamline Certification for Labs Testing for COVID-19. READ MORE

9/24/2020 - MLN Matters MM11937 revised 9/24/20. Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment. READ MORE 

9/8/2020 - All CLIA certified facilities performing SARS-CoV-2 testing are required to report all results, positive and negative, to their state or local health departments. CMS will enforce the SARS-CoV-2 test results reporting requirement. READ MORE

8/31/2020 - What is CMS’s policy regarding laboratories performing antigen tests authorized by the Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) for use at the point of care (POC) or in patient care settings operating under a Clinical Laboratory Improvement Amendments of 1988 (CLIA) Certificate of Waiver on asymptomatic individuals? READ MORE 

8/28/2020 - MLN Matters R10331CP issued 8/28/2020 - October 2020 Update of the Hospital Outpatient Prospective Payment System (OPPS). The October 2020 revisions to I/OCE data files, instructions, and specifications are provided. READ MORE

8/26/2020 - Interim Final Rule (IFC), CMS-3401-IFC, Updating Requirements for Reporting of SARS-CoV-2 Test Results by (CLIA) of 1988 Laboratories, and Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency. READ MORE 

8/21/2020 - MLN Matters MM11937 Revised 8/21/2020 "Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment." READ MORE 

8/21/2020 - MLN Matters 8/21/20 R10318CP "Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment." READ MORE

8/7/2020 - Quarterly Update for Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment. Transmittal R10265CP issued 8/7/20, Implementation Date 10/5/20 and Effective Date 10/1/20. READ MORE 

7/30/2020 - Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests - CMS Public Meeting. READ MORE

7/30/2020 - MLN Connects 7/30/2020. COVID-19: Laboratory Claims Requiring the NPI of the Ordering/Referring Professional - UPDATE. READ MORE 

7/30/2020 - MLN Matters Article - Addition of the QW Modifier to Healthcare Common Procedure Coding System (HCPCS) Code 87426 READ MORE

7/24/2020 - CMS Transmittal R10231OTN issued 7/24/2020, CR 11927, Implementation Date 10/5/2020 - Addition of the QW modifier to HCPCS Code 87426. READ MORE

7/8/2020 - MLN Matters MM11815 Revised 7/8/2020, Effective 7/1/2020, Implementation 7/6/2020. READ MORE 

6/25/2020 - New Codes Effective June 25, 2020. The listed new code will be added manually to the national HCPCS file by the MACs with an effective date of June 25, 2020. Also, this new code is contractor-priced (where applicable) until it is nationally priced and undergoes the CLFS annual payment determination process in accordance with the Social Security Act § 1833(h)(8), § 1834A(c) and § 1834(A)(f).

Proprietary Laboratory Analysis (PLAs). The listed new codes will be manually added to the national HCPCS files by the MACs with an effective date of June 25, 2020. Also, these new codes are contractor-priced (where applicable) until they are nationally priced and undergo the CLFS annual payment determination process in accordance with the Social Security Act § 1833(h)(8), § 1834A(c) and § 1834(A)(f). MACs shall only price PLA codes for laboratories within their jurisdiction.

6/19/2020 - COVID-19 Frequently Asked Questions on Medicare Fee-for-Service (FFS) Billing. READ MORE

6/18/2020 - MLN Connects 6/18/2020. COVID-19 Diagnostic Laboratory Tests: Billing for Clinician Services. READ MORE

6/12/2020 - MLN Matters MM11815 released 6/12/2020 and effective 7/1/2020. Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment. READ MORE

6/11/2020 - MLN Connects 6/11/2020. HHS Announces New Laboratory Data Reporting Guidance for COVID-19 Testing. READ MORE

6/9/2020 - CMS Transmittal R10166CP release date 6/8/2020, Implementation Date 7/1/2020, CR 11814. July 2020 Update of the Hospital Outpatient Prospective Payment System (OPPS), COVID-19 Laboratory Tests and Services and Other Laboratory Tests Coding Update. READ MORE

6/4/2020 - Ordering COVID-19 Diagnostic Laboratory Tests. READ MORE

5/28/2020 - MLN Matters MM11805 Effective 6/12/2020. READ MORE

5/12/2020 - MLN Connects Special Edition 5/12/2020: The Coronavirus Aid, Relief, and Economic Security (CARES) Act requires providers of diagnostic tests for COVID-19 to post the cash price for a COVID-19 diagnostic test on their website from March 27 through the end of the public health emergency. READ MORE

5/8/2020 - MLN Matters 5/8/2020. SE20017 Release Date 5/7/2020: Medicare-enrolled pharmacies and other Medicare-enrolled suppliers, or pharmacies and suppliers seeking to enroll temporarily as independent clinical diagnostic laboratories to help address the urgent need for COVID-19 testing. READ MORE

5/7/2020 - MLN connects 5/7/2020. COVID-19: Modified Ordering Requirements for Laboratory Billing. During the COVID-19 Public Health Emergency, any health care professional authorized under state law may order tests.
READ MORE

4/30/2020 - Federal government announces another round of sweeping regulatory waivers and rule changes to deliver expanded care to the nation’s seniors and provide flexibility to the healthcare system as America reopens. READ MORE

4/22/2020 - MLN Connects 4/23/2020. Clinicians may now earn credit in the Merit-based Incentive Payment System (MIPS), a performance-based track of QPP that incentives quality and value, for participation in a clinical trial and reporting clinical information by attesting to the new COVID-19 Clinical Trials improvement activity. READ MORE

4/15/2020 - CMS Ruling 2020-1-R dated 4/14/2020. This Ruling articulates CMS policy concerning the payment under MCR B for clinical diagnostic laboratory tests (CDTLs) for the detection of SARS-CoV-2 or the diagnosis of the virus that causes COVID-19 making use of high throughput technologies EFFECTIVE March 18, 2020. This training and these processes represent an increase in resources, bringing the total resources required for these tests to $100 (a more accurate payment than the one currently in use via contractor pricing). READ MORE

4/15/2020 - MLN Connects 4/16/2020: MLN Matters MM11691 3/25/2020 Effective 4/1/2020 - New Corona Virus Lab Tests HCPCS Codes U0001, U0002, and 87635. Medicare covers medically necessary and reasonable clinical diagnostic laboratory tests when ordered by a physician or non-physician practitioner who is treating the patient. READ MORE

MLN Connects 4/16/2020: MLN Matters MM11681 4/3/2020 Effective 4/1/2020 - This article on April 6, 2020 reflects revisions to CR11681. The CR revisions added code 87635 to the HCPCS file, effective March 13, 2020, added two new COVID-19 codes (G2023 and G2024), effective March 1, 2020, and removed the section on the delay of the CLFS reporting period. READ MORE

4/10/2020 - Payment for Specimen collection: Independent laboratories can bill for the specimen collection fee if the specimen is collected by trained laboratory personnel from a homebound or non-hospital inpatient and the specimen is a type that would not require only the services of a messenger pick up service. READ MORE

3/31/2020 - Clinical diagnostic laboratories: To identify and reimburse specimen collection for COVID-19 testing, CMS established two Level II HCPCS codes, effective with line item date of service on or after March 1, 2020. READ MORE

3/24/2020 - Change Request (CR) 11640 informs the MACs about new HCPCS codes for 2020 that are subject to and excluded from Clinical Laboratory Improvement Amendment (CLIA) edits. READ MORE

3/12/2020 - Clinical diagnostic laboratories: To identify and reimburse specimen collection for COVID-19 testing, CMS established two Level II HCPCS codes, effective with line item date of service on or after March 1, 2020. READ MORE

3/12/2020 - April 1, 2020, laboratories performing the COVID-19 test can bill Medicare and other health insurers for services that occurred after February 4, 2020, using the newly created HCPCS code (U0001).  READ MORE

Local Medicare Administrative Contractors (MACs) are responsible for developing the payment amount for claims they receive for these newly created HCPCS codes in their respective jurisdictions until Medicare establishes national payment rates. A listing of the Test Price by Medicare Administrative Contractor (MAC) is available. READ MORE

12/1/2020 - As the first COVID-19 vaccines are being distributed across the country, we are committed to ensuring that: Cigna commercial and Medicare customers receive the COVID-19 vaccine with no out-of-pocket costs and according to the federal and state priority grouping. Providers receive timely information and reasonable reimbursement consistent with CMS rates for administering EUA-approved COVID-19 vaccines and treatments. READ MORE

4/16/2020 - Updated General Billing Guidance for COVID-19 testing through at least May 31, 2020. READ MORE

3/26/2020 - New HCPCS codes U0001 and U0002 have been released for dates of service on or after February 4, 2020. READ MORE

6/8/2020 - COVID-19 Diagnostic & Antibody Testing Administrative Policy and Information for all Lines of Business.
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6/4/2020 - For its commercial members, the Health Plan provides coverage with no member cost-share for COVID-19 diagnostic/viral testing as well as antibody testing that is determined to be medically appropriate for the diagnosis and treatment of an individual by an attending provider as evidenced by an order from the attending provider. READ MORE

5/21/2020 - COVID-19 Diagnostic and Antibody Testing Information. READ MORE

4/17/2020 - Under new guidance from the Internal Revenue Service, members with high deductible health plans will not be responsible for copayments and/or coinsurance for COVID-19-related testing, even if their deductible has not been met. READ MORE

3/26/2020 - Report U0001, U0002 or 87635, as directed by American Medical Association guidance (refer to AMA link below) members with high deductible health plans will not be responsible for copayments and/or coinsurance for COVID-19-related testing, even if their deductible has not been met. READ MORE

4/5/2022 - Fee Schedule News 4/5/22. COVID-19: Allowances for Laboratory Test Codes. READ MORE 

2/27/2022 - 2022 Payment Rates for COVID-19 vaccine and monoclonal administration. READ MORE

1/25/2022 - First Coast Claims Processing Issue for Part B Providers; Posted 1/25/2022. Revised editing for ordering/referring providers on lab claims. READ MORE

1/25/2022 - Provider Specialty News/Clinical Lab/Part B. Duplicate editing for COVID-19 laboratory services.
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11/8/2021 - First Coast Processing Issues. Allowance of QW modifier on codes U0002 and 87635. READ MORE 

7/28/2021 - First Coast Processing issues. Revised Editing for Ordering/Referring Providers on Lab Claims - Part B Only. READ MORE 

1/12/2021 - COVID-19 Fee Schedule News: Allowances for Laboratory Test Codes. READ MORE 

11/20/2020 - COVID-19 Fee Schedule News: Allowances for Laboratory Test Codes. READ MORE 

10/21/2020 - COVID-19 Fee Schedule News: Allowances for Laboratory Test Codes. READ MORE 

7/10/2020 - COVID-19: Allowances for laboratory test codes U0001-U0004, 0223U, 0224U, 87426 and 87635. READ MORE

6/4/2020 - Part B News - Duplicate editing for COVID-19 laboratory services. READ MORE

4/28/2020 - Allowances for laboratory test codes U0001-U0004 and 87365. READ MORE

12/7/21 - COVID-19 Update: The FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to share the latest information, including FDA recommendations for clinical laboratory staff and health care providers. READ MORE 

11/15/2021 - FDA Updates Test Policies to Help to Ensure Accuracy and Reliability of Tests and Increase Access to At-Home Tests. READ MORE 

11/12/2021 - On November 9, 2021, the FDA posted an updated Molecular and Antigen Home Use Test Template intended to assist test developers and facilitate the Emergency Use Authorization (EUA) request and Pre-EUA submission processes for COVID-19 tests. READ MORE 

4/20/2021 - COVID-19 Update: Today, the FDA took steps to further facilitate the authorization of tests for pooling specimens from asymptomatic individuals in serial testing programs. READ MORE 

4/2/2021 - COVID-19 Update: This week, the FDA posted a new web page SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests for clinical laboratory staff and health care providers about the impact of viral mutations on COVID-19 molecular, antigen, and serology tests. READ MORE 

3/26/2021 - COVID-19 Update 3/26/21. ** On March 23, 2021, the FDA issued an emergency use authorization (EUA) to the Twist Bioscience Corporation for their SARS-CoV-2 NGS Assay. READ MORE 

12/28/2020 - COVID-19 Update 12/28/20. On Dec. 23, the FDA updated the Device Shortage List on our web page that lists Medical Device Shortages during the COVID-19 Public Health Emergency. READ MORE 

12/22/2020 - Tests and sample collection devices are authorized by the FDA under EUAs. These include 233 molecular tests and sample collection devices, 62 antibody tests, and 11 antigen tests. There are 32 molecular prescription at home test, one antigen prescription at home test, and one over the counter (OTC) at-home antigen test. READ MORE 

12/15/2020 - Virtual Town Hall Series: Coronavirus (COVID-19) Test Development and Validation. READ MORE

11/24/2020 - The FDA posted two templates with recommendations on what to include in EUA requests for serology tests. READ MORE 

11/19/2020 - FDA issued an EUA for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). READ MORE 

11/3/2020 - COVID-19 Update. Today, the FDA alerted clinical laboratory staff and health care providers that false positive results can occur with antigen tests for the rapid detection of SARS-CoV-2. READ MORE 

11/9/2020 - The FDA issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. READ MORE 

11/4/2020 - Virtual Town Hall Series: Coronavirus (COVID-19) Test Development and Validation. READ MORE

10/26/2020 - The FDA updated the Antigen Template for Test Developers.READ MORE

9/30/2020 - The U.S. Food and Drug Administration (FDA) updated the SARS CoV-2 reference panel comparative data on FDA’s website to reflect the latest information. READ MORE 

9/18/2020 - The FDA reissued the Emergency Use Authorization (EUA) for the Abbott ID Now COVID-19 test.
READ MORE 

8/19/2020 - The FDA issued the third Emergency Use Authorization (EUA) for a COVID-19 antigen test. READ MORE 

8/12/2020 - The FDA recently issued two Emergency Use Authorizations for molecular tests.
READ MORE 

8/11/2020 - FDA has issued Emergency Use Authorizations to the following companies for their respective tests: Solaris Diagnostics, for its molecular Solaris Multiplex SARS-CoV-2 Assay and Alpha Genomix Laboratories, for its molecular Alpha Genomix TaqPath SARS-CoV-2 Combo Assay. READ MORE

8/10/2020 - FDA issued an Emergency Use Authorization to George Washington University Public Health Laboratory for its GWU SARS-CoV-2 RT-PCR Test. READ MORE 

8/7/2020 - On August 6, the FDA revoked the emergency use authorization (EUA) for Autobio Diagnostics Co., Ltd.’s, Anti-SARS-CoV-2 Rapid Test, a SARS-CoV-2 antibody test, due to performance concerns with the accuracy of the test.
READ MORE 

8/4/2020 - FDA recently issued Emergency Use Authorizations (EUAs) to more companies for their respective devices and tests. READ MORE 

8/3/2020 - COVID-19 Update 8/3/2020. The FDA issued emergency use authorizations (EUAs) to Siemens for its ADVIA Centaur SARS-CoV-2 IgG (COV2G) and Atellica IM SARS-CoV-2 IgG (COV2G) tests, which are the first COVID-19 serology tests that display an estimated quantity of antibodies present in the tested individual’s blood. READ MORE

7/29/2020 - COVID-19 Daily Update. On July 29, the FDA posted frequently asked questions for patients and consumers about antibody (serology) testing during the COVID-19 public health emergency. READ MORE

7/29/2020 - The U.S. Food and Drug Administration posted a new template for commercial developers to help them develop and submit emergency use authorization (EUA) requests for COVID-19 diagnostic tests that can be performed entirely at home or in other settings besides a lab, such as offices or schools, and that could be available without a prescription. READ MORE 

7/29/2020 - On July 28, the FDA updated the Molecular Diagnostic templates. READ MORE 

7/28/2020 - FDA issued emergency use authorizations (EUAs) for two molecular diagnostic tests for the qualitative detection of SARS-CoV-2 to Eli Lilly and Company, for its Lilly SARS-CoV-2 Assay and Sandia National Laboratories, for its SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay. READ MORE

7/27/2020 - On July 24, FDA issued emergency use authorizations (EUAs) to two companies for serology-based tests for the qualitative detection and differentiation of IgG and IgM antibodies to SARS-CoV-2. READ MORE

7/24/2020 - FDA Authorizes 1st Diagnostic Test for Screening of People without Known or Suspected COVID-19 Infection. READ MORE 

9/2/2020 - Virtual Town Hall Series - Immediately in Effect Guidance on COVID-19 Diagnostic Tests. READ MORE

8/7/2020 - Virtual Town Hall Series - Immediately in Effect Guidance on COVID-19 Diagnostic Tests. VIEW SLIDES

8/3/2020 - Virtual Town Hall Series - Immediately in Effect Guidance on COVID-19 Diagnostic Tests. VIEW SLIDES

7/29/2020 - Virtual Town Hall Series - Immediately in Effect Guidance on COVID-19 Diagnostic Tests. VIEW SLIDES

7/23/2020 - The FDA updated the Testing Supply Substitution Strategies slide show. READ MORE 

7/23/2020 - In a new FDA Voices, titled FDA’s Continued Commitment to the Safety and Security of Our Laboratories, agency leaders explain that laboratory safety is of the highest priority in all of the agency’s scientific research and analytical facilities. READ MORE 

7/18/2020 - The FDA issued it's first emergency authorization for Sample Pooling in COVID-19 Diagnostic Testing.
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7/14/2020 - FDA Daily Update 7/14. READ MORE             

7/8/2020 - False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System. READ MORE 

7/8/2020 - The FDA updated the Molecular Diagnostic templates on FDA.gov to provide more detailed recommendations for the validation of assays intended to be used for pooling patient samples. READ MORE

7/6/2020 - On July 2, 2020, the U.S. Food and Drug Administration (FDA) issued the second Emergency Use Authorization (EUA) for a COVID-19 antigen test. READ MORE

7/2/2020 - FDA Authorizes Additional COVID-19 Combination Diagnostic Test Ahead of Flu Season. READ MORE

6/30/2020 - The FDA took action to help facilitate the timely development of safe and effective vaccines to prevent COVID-19 by providing guidance with recommendations related to licensure for those developing COVID-19 vaccines. READ MORE

6/29/2020 - FDA issued Emergency Use Authorizations (EUAs) for the following SARS-CoV-2 molecular diagnostic tests. READ MORE  

6/29/2020 - Facilitating Diagnostic Test Availability for Asymptomatic Testing and Sample Pooling.READ MORE

6/19/2020 - The FDA issued a Letter to Clinical Laboratory Staff and Health Care Providers recommending that they stop using COVID-19 antibody tests that are listed on the FDA’s “removed” test list. READ MORE

6/18/2020 - Virtual Town Hall Series - Immediately in Effect Guidance on COVID-19 Diagnostic Tests. VIEW SLIDES

FDA Takes Additional Action to Harness Real-World Data to Inform COVID-19 Response Efforts. READ MORE

The FDA published the Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry. READ MORE

6/15/2020 - The FDA revoked the emergency use authorization (EUA) of the Chembio Diagnostic System, Inc.’s, DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test, due to performance concerns with the accuracy of the test.
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6/15/2020 - The FDA revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation in a clinical trial was not feasible. READ MORE

6/10/2020 - FDA and NIH have made updates to the CURE ID crowd-sourcing app to make it easier for healthcare providers to share — via mobile device or website — their experiences treating COVID-19 patients who are unable to be enrolled in a clinical trial. READ MORE

The FDA issued an emergency use authorization (EUA) to Illumina, Inc., for the first COVID-19 diagnostic test utilizing next-generation sequence technology. READ MORE

6/5/2020 - The FDA is changing the hours for the COVID-19 Industry Hotline (1-888-INFO-FDA, press *). READ MORE

6/4/2020 - FDA Publicly Shares Antibody Test Performance Data From Kits as Part of Validation Study. READ MORE

6/3/2020 - The FDA announced a new web-based resource, titled Testing Supply Substitution Strategies. READ MORE

6/2/2020 - COVID-19 Update: FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection. READ MORE

5/22/2020 - The FDA updated the FAQs on Testing for SARS-CoV-2 to clarify information about at-home self-collection and what tests should no longer be distributed for COVID-19. READ MORE

5/21/2020 - FDA Provides Promised Transparency for Antibody Tests. READ MORE

5/16/2020 - The U.S. Food and Drug Administration has issued and Emergency Use Authorization(EUA) to Everlywell, Inc. for the Everlywell COVID-19 Test Home Collection Kit. READ MORE

5/15/2020 - The U.S. Food and Drug Administration is alerting the public about the Abbott ID NOW point-of-care test to diagnose COVID-19 returning possibly false negative results. READ MORE

5/9/2020 - The U.S. Food and Drug Administration has issued the first emergency use authorization (EUA) for a COVID-19 antigen test. READ MORE

5/8/2020 - The U.S. Food and Drug Administration authorized the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing. READ MORE

5/4/2020 - Insight into FDA's Revised Policy on Antibody Tests. Antibody tests are not meant for use to diagnose active SARS-CoV-2 infection. READ MORE

The FDA is introducing a more streamlined process to support EUA submissions and review. Two voluntary EUA templates for antibody tests have been made available – one for commercial manufacturers, and one for CLIA certified high-complexity labs who decide to seek FDA authorization. READ MORE

4/28/2020 - COVID-19 Daily Roundup News. Diagnostics update to date. READ MORE

4/24/2020 - During the COVID-19 pandemic, the FDA has worked with more than 380 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. READ MORE

4/21/2020 - FDA News Release: The FDA authorized the first diagnostic test with a home collection option for COVID-19. Specifically, the FDA re-issued the emergency use authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.  READ MORE

4/16/2020 - FDA News Release - Daily COVID-19 Update. READ MORE

4/13/2020 - The FDA has worked with more than 300 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. To date, 34 emergency use authorizations have been issued for diagnostic tests. The FDA has been notified that more than 180 laboratories have begun testing under the policies set forth in their COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019. The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date. READ MORE 

3/16/2020 - The FDA put in place a policy for states to take responsibility for tests developed and used by laboratories in their states. The agency does not intend to object to commercial manufacturers distributing and labs using new commercially developed tests prior to the FDA granting an EUA, under certain circumstances. READ MORE

9/10/2020 - HHS seeks to obtain information regarding the ability of CLIA-certified/ accredited commercial, academic, medical center, and public health laboratories to feasibly provide additional COVID–19 testing capability if supplementary testing instruments were made available. READ MORE

8/19/2020 - This week the U.S. Food and Drug Administration granted an Emergency Use Authorization (EUA) for LumiraDx UK Ltd.’s LumiraDx SARS-CoV-2 Ag Test. READ MORE 

8/13/2020 - The U.S. Department of Health and Human Services announced combined investments of $6.5 million in two commercial diagnostic laboratories to expand capacity to conduct up to 4 million additional SARS-CoV-2 per month. READ MORE 

8/4/2020 - COVID-19 Portal Update. READ MORE 

7/27/2020 - The U.S. Department of Health and Human Services today reserved the available advanced manufacturing capability and capacities of the Center for Innovation in Advanced Development and Manufacturing (CIADM) at the Texas A&M University System for use in manufacturing COVID-19 vaccines. READ MORE 

7/27/2020 - Phase 3 Clinical Trial of Investigational Vaccine for COVID-19 Begins. READ MORE 

7/22/2020 - NHI leadership details unprecedented initiative to ramp up testing technologies for COVID-19. READ MORE 

7/21/2020 - HHS Announces National COVID-19 Testing Implementation Forum. READ MORE 

7/14/2020 - Trump Administration Announces Initiative for More and Faster COVID-19 Testing in Nursing Homes. 
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6/4/2020 - HHS Announces New Laboratory Data Reporting Guidance for COVID-19 Testing.  READ MORE

6/1/2020 - As part of the Trump Administration’s Operation Warp Speed, on Monday, the U.S. Department of Health and Human Services announced a task order with Emergent BioSolutions to advance manufacturing capabilities and capacity for a potential COVID-19 vaccine as well as therapeutics.  READ MORE

5/29/2020 - COVID-19 Specimen-only collection. The following codes may be used when collecting specimens for the diagnostic purposes of COVID-19. Reimbursement for specimen collection will, in general, only be separately reimbursed if it is the ONLY code billed on the claim. If billed with another code, such as an E&M code, no separate reimbursement will be allowed. CPT/HCPC Codes: 99000, 99001, 99211 (per CMS Guidelines published on 4/30/2020), G9803, G2023 and G2024. Refer to the chart for the description of these services and who can use them. READ MORE

5/20/2020 - COVID-19 Testing. Three codes have been created for providers and laboratories to allow billing for COVID-19 patient tests. Highmark will reimburse each code at the contracted rate or Highmark established Fee Schedule for that service. When filing the COVID-19 testing and office visits claims, only use one code for COVID-19 testing.
READ MORE

3/19/2020 - Effective April 1, 2020, Highmark will reimburse the following codes at the CMS rate- U0001, U0002, 87365 for dates of service beginning with February 4, 2020. Only use one code for COVID-19 testing. Other services provided during the visit may be billed on the same claim but as a separate claim line with the appropriate CPT/HCPC codes. All cost shares will be waived for all Medicare Advantage, ACA, and select employer plans. READ MORE

3/6/2020 - Highmark will waive prior authorization requirements for the COVID-19 diagnostic test when recommended by a medical professional. Additionally, the COVID-19 diagnostic test will be covered without cost-sharing. This would mean that cost-sharing (i.e. deductibles, co-payments and coinsurance) associated with the COVID-19 diagnostic test ordered by a medical professional will be waived for all members. READ MORE

8/27/2020 - CPT Code for COVID-19 Testing Exempt from AB 97 10% Payment Reduction. READ MORE 

7/30/2020 - CPT Code for COVID-19 Testing Now a CLIA-Waived Test. READ MORE 

7/30/2020 - Medi-Cal Reimbursement for Clinical Laboratory Services Related to the 2019 Novel Coronavirus.
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5/28/2020 - DHCS has agreed to reimburse the two serology testing codes (CPT codes 86769 and 86328) at 100% of the Medicare rate and to waive the extra AB 97 10% payment reduction. DHCS will let CCLA know once the Fiscal Intermediary confirms when the rates will be uploaded on the fee schedule. READ MORE

The reimbursement rates for the codes are as follows:

• CPT code 86769 = $42.13
• CPT code 86328 = $45.23

5/21/2020 - New COVID-19 Specimen Collection Rate. In response to the coronavirus disease 2019 (COVID-19), the Centers for Medicare & Medicaid Services (CMS) established HCPCS code C9803 for specimen collection in a hospital outpatient clinic setting, among other codes. Accordingly, the Department of Health Care Services (DHCS) is establishing a reimbursement rate for the new code. The rate is based on the most recent corresponding Medicare rate, and is reimbursed at 100 percent of the Medicare rate. It is exempt from the ten percent payment reductions in Welfare and Institutions Code (W&I Code) Section 14105.192.

Upon expiration of the public health emergency or national emergency, this rate will be amended to correspond with the clinical laboratory services methodology in W&I Code Section 14105.22, including the application of the Assembly Bill 97 (AB 97) payment reduction. The updated manual pages reflecting this change will be released in a future Medi-Cal Update. READ MORE

5/12/2020 - COVID-19 Specimen Collection is a new Medi-Cal Benefit. Effective for dates of service on or after March 1, 2020, HCPCS Code C9803 (hospital outpatient clinic visit specimen collection for Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-COV-2] [Coronavirus Disease COVID-19]) is a new Medi-Cal benefit. C9803 has a frequency limit of two collections per day and can be billed with any ICD-10-CM code. This code is a Presumptive Eligibility (PE) service and is not reimbursable when billed with codes G2023 or G2024. An Erroneous Payment Correction (EPC) will be initiated to reprocess affected claims. Specific billing policy related to C9803 will be released in a future Medi-Cal Update. READ MORE

Additional Guidance on Presumptive Eligibility (PE) for COVID-19. The Presumptive Eligibility (PE) for Coronavirus (COVID-19) was implemented on April 8, 2020. PE for COVID-19 allows individuals to seek the necessary diagnostic testing, testing-related services, and treatment services, including all medically necessary care as a result of COVID-19. 

Providers are to render the COVID-19 diagnostic testing, testing-related services, and treatment services, including all medically necessary care for the individual at the time of the individual’s visit to the office, clinic, or hospital. Questions: Questions concerning PE for COVID-19 should be sent to COVID19Apps@dhcs.ca.gov. READ MORE

5/6/2020 - The Department of Health Care Services (DHCS) is establishing reimbursement rates with an effective date of service of March 18, 2020 for CPT codes 86328, 86769 and dates of service April 10, 2020 for U0003, U0004 for COVID-19 testing. READ MORE

5/1/2020 - Effective for dates of service on or after March 20, 2020, claims for HCPCS codes U0002 and CPT® code 87635 may be billed with modifier QW to indicate the provider is performing the procedure using a Clinical Laboratory Improvement Amendments (CLIA)-waived test kit. Providers should ensure they have a valid, current CLIA certificate before submitting claims for these codes with the QW modifier. An Erroneous Payment Correction (EPC) will be implemented to reprocess affected claims. READ MORE

4/7/2020 - Effective for dates of service on or after April 10, 2020, the American Medical Association (AMA) has released specific CPT® codes to report and track COVID-19 antibody testing. Codes 86328 and 86769 each have a frequency limit of two per day and may not be billed with each other on the same date of service. All three codes have been determined to be Medi-Cal benefits. READ MORE

Effective for dates of service on or after March 1, 2020, HCPCS codes G2023 (specimen collect covid-19) and G2024 (spec coll snf/lab covid-19) are now Medi-Cal benefits. These codes are billable by clinical diagnostic laboratories. READ MORE

3/27/2020 - The State Controller’s Office (SCO) will print and mail the paper Remittance Advice Details (RAD) and Medi-Cal Financial Summary up to four (4) business days later than the warrant itself. The Medi-Cal Checkwrite Schedule itself remains unchanged. READ MORE

3/19/2020 - Effective for dates of service on or after February 4, 2020, HCPCS code U0001 (2019-Novel Coronavirus [2019-nCoV diagnostic p]) and HCPCS code U0002 (COVID-19 lab test non-cdc) are new Medi-Cal benefits. READ MORE

3/17/2020 - New HCPCS codes U0001 and U0002 retroactively to date of service February 4, 2020. HCPCS code U0001 is billable for the tests developed by the CDC, and will be on the Medi-Cal Fee schedule at $35.91 for COVID-19. HCPCS code U0002 is billable for non-CDC laboratory tests for and will be on the Medi-Cal fee schedule at $51.31 for COVID-19. READ MORE

7/31/2020 - COVID-19 Test Kits from Carolina Liquid Chemistries granted FDA EUA. READ MORE 

7/23/2020 - NIH Leadership Details Initiative to Ramp Up Testing Technologies for COVID-19.  READ MORE

7/14/2020 - Disease/Infectious Disease.  Sonora Quest collaborates with state and healthcare leaders to expand COVID-19 testing in AZ. READ MORE

7/14/2020 - Disease/Infectious Disease. Simple blood test can predict severity of COVID-19 for some patients.
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7/13/2020 - Disease/Infectious Disease. WHO: Aggressive Action Needed to Turn COVID-19 Around. READ MORE

7/13/2020 - Diagnostics/Assays News.  Diazyme receives FDA EUA for COVID-19 Antibody Test.  READ MORE

11/2/2020 - The CS modifier should not be applied to laboratory test services since deductible and co-insurance does not apply. READ MORE 

6/9/2020 - NGS Update on Claims for COVID-19 Testing. READ MORE

4/21/2020 - Two new HCPCS codes, U0003 and U0004, have been created for laboratories to bill for the detection of SARS–CoV–2 or the diagnosis of the virus that causes COVID–19. These codes are effective for dates of service on and after 4/14/2020 and will remain active until the end of the public health emergency. The new HCPCS codes are paid under the Medicare CLFS at the rate of $100. There is no beneficiary cost-sharing under Original Medicare. READ MORE

3/27/2021 - NYS Medicaid Laboratory Services Fee Schedule lists HCPCS code U0002 and CPT code 87635 with a reimbursement of $51.31. These billing codes allow laboratories to bill for non-CDC laboratory tests for COVID-19. Only one code should be used. READ MORE

2/17/2021 - In accordance with CMS, the fees for high throughput tests will be reduced to $75 effective 01/01/2021. For dates of service on or after 01/01/2021, U0005 may be billed as an add on code, when appropriate. READ MORE 

5/25/2022 - Billing and Coding: MolDX - Molecular Syndromic Panels for Infectious Disease Pathogen Identification Testing (A58726) - R3 - Effective June 02, 2022. READ MORE

Billing and Coding: MolDx - Molecular Syndromic Panels for Infectious Disease Pathogen Identification Testing (A58720) - R3 - Effective June 02, 2022. READ MORE 

6/30/2021 - COVID-19 Lab Test Denials: Noridian has been seeing many denials for COVID lab test codes, U0003 (Infectious agent detection by nucleic acid (DNA or RNA); COVID-19, use of high throughput technologies) and U0005 (Add-on to U0003, U0004 when tests are completed within two calendar days or less of specimen collection). These denials occur when labs tests are being billed to Part B in error from physicians. READ MORE

6/11/2021 - Noridian Alert. Denials for U0002QW and 87635QW. Provider/Supplier Type(s) Impacted: Clinical Laboratory Improvement Amendment (CLIA) waived laboratory providers. Resolved 6/9/21. READ MORE

5/27/2021 - Noridian Alert. Denials for U0002QW and 87635QW. Provider/Supplier Type(s) Impacted: Clinical Laboratory Improvement Amendment (CLIA) waived laboratory providers. READ MORE 

11/12/2020 - Billing and Coding: MolDX: Multiplex Nucleic Acid Amplified Tests for Respiratory Viral Panels - R10. This coverage article has been revised. READ MORE 

10/22/2020 - Novitas Fee Schedules: New Codes for Laboratory Tests for the Novel COVID-19. READ MORE 

6/4/2020 - Duplicate editing for COVID-19 laboratory services. Generally, duplicate editing prevents payment on claim lines that contain the same procedure code as previously paid services. If initial testing is negative, but the suspicion for COVID-19 remains, and it is important for the management of the patient or infection control, repeating the test is appropriate. READ MORE

4/30/2020 - COVID-19 News. New codes for laboratory tests for the novel coronavirus (COVID-19). The Centers for Medicare & Medicaid Services has established new codes for laboratory tests for COVID-19. READ MORE

3/26/2020 - SummaCare is waiving any co-pays and deductibles related to provider-ordered testing of COVID-19 for Medicare Advantage, Individual and Commercial members regardless of where the test is ordered and performed. Self-insured plans will determine how their coverage will apply.

SummaCare is in compliance with CMS coding guidelines for COVID-19 lab testing. CMS adopted two CPT codes, (U0001) and (U0002) effective 02/04/2020, for COVID-19 testing. SummaCare will accept CPT code 87635 (effective 03/13/2020) or HCPCS Level II U0002 for the COVID-19 testing. There are no special modifiers at this time. 

1/1/2021 - Effective January 12, 2021, for dates of service on or after January 1, 2021, the reimbursement rates for COVID-19 related procedure codes U0003, U0004, and U0005 have been updated. READ MORE       

6/4/2020 - COVID-19 Testing Procedure Codes. Additional information is available for coronavirus testing procedure codes that became a benefit of Texas Medicaid effective for dates of services on or after February 4, 2020. READ MORE

6/4/2020 - Update to the article titled, "Coronavirus Testing Procedure Codes to Become a Benefit," which was published on the website March 16, 2020. The article stated procedure code U0002 is a benefit of Texas Medicaid and the Children with Special Health Care Needs (CSHCN) Services Program for dates of service on or after February 4, 2020. The Centers for Medicare & Medicaid Services (CMS) has categorized procedure code U0002 as a Clinical Laboratory Improvement Amendments (CLIA) waived test. Effective for dates of service on or after March 20, 2020, procedure code U0002 must be submitted with modifier QW. READ MORE

5/8/2020 - During the national public health emergency period, UnitedHealthcare will cover FDA-authorized COVID-19 antibody tests ordered by a physician or appropriately licensed health care professional without cost sharing (copayment, coinsurance or deductible). READ MORE

5/4/2020 - UnitedHealthcare will cover FDA-authorized COVID-19 antibody tests ordered by a physician or appropriately licensed health care professional without cost sharing (copayment, co-insurance or deductible). READ MORE

5/8/2020 - During the national public health emergency period, UnitedHealthcare will cover FDA-authorized COVID-19 antibody tests ordered by a physician or appropriately licensed health care professional without cost sharing (copayment, coinsurance or deductible).  READ MORE

5/4/2020 - The national public health emergency, as renewed, will end on July 25, 2020. COVID-19 testing is rapidly evolving and UnitedHealthcare will continue to provide updates as they become available. Be sure to check back often for the latest information. READ MORE

5/4/2020 - UnitedHealthcare will cover FDA-authorized COVID-19 antibody tests ordered by a physician or appropriately licensed health care professional without cost sharing (copayment, co-insurance or deductible). This coverage applies to members enrolled in Medicare Advantage, Medicaid, and Individual and Group Market health plans. Benefits will be otherwise adjudicated in accordance with the member’s health plan. READ MORE

4/23/2020 - COVID-19 Testing Coverage Expanded: UnitedHealthcare is waiving cost sharing for COVID-19 testing during this national emergency for Medicare Advantage, Medicaid, Individual and Group Market health plans. READ MORE

4/23/2020 - Claim Coding, Submissions and Reimbursement: Laboratory Billing Scenarios. READ MORE

3/26/2020 - Use new CPT code 87635 for lab testing for severe acute respiratory syndrome coronavirus 2 (SARS-2-CoV-2). CMS created the following HCPCS codes for COVID-19 testing performed on or after Feb. 4, 2020: HCPCS U0001: This code is used for the laboratory test developed by the CDC. HCPCS U0002: This code is used for the laboratory test developed by entities other than the CDC. READ MORE

3/20/2020 - Cost sharing is waived for COVID-19 tests and FAQs. This coverage applies to Medicare Advantage, Medicaid and employer-sponsored plans. READ MORE

6/10/2020 - COVID-19 Hotline updated 7/13/2020. READ MORE

6/10/2020 - Modifiers used during the COVID-19 Public Health Emergency. Modifiers are CS, CR, 95 and CG, and Condition Code DR. Refer to the full article for the specific billing requirements and circumstances for billing.
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6/10/2020 - WPS GHA Claims Processing Alert. WPS identified an issue where COVID-19 codes G2023, G2024, U0001, U0002, and 87635 were not being allowed for dates of service prior to April 1, 2020. READ MORE

4/27/2020 - Modifier CS and COVID-19 Testing. A new law waives cost-sharing under Medicare Part B for certain outpatient COVID-19 testing-related services. The CS modifier signals the MACs to pay 100% for these services. This applies for claims with dates of service on or after March 18, 2020. Claims submitted without the modifier may be resubmitted. READ MORE