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Lab Testing Guidance for COVID-19

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COVID-19 Diagnostic(Updated March 31, 2020): On March 13, 2020, President Trump declared a National Emergency[1] related to the current Coronavirus / COVID-19 outbreak.  The declaration gives Secretary Alex Azar of the US Department of Health & Human Services (HHS) the power to waive certain Federal requirements in Medicare, Medicaid and CHIP in order to address the outbreak. The President’s declaration was preceded by Secretary Azar’s determination on January 31, 2020[2] that a public health emergency exists.  Since these pronouncements, Liles Parker attorneys have received numerous calls asking for clarification on these waivers and other guidance from HHS and the Centers for Medicare and Medicaid Services (CMS).  Our clients have also asked that we provide a listing of useful links and other available resources.  This article will detail the information related to lab operations and billing for COVID-19 diagnostic tests to CMS, as well as billing for COVID-19 diagnostic tests for private payors.

I.   Authorization for Use of COVID-19 Testing:

On February 6, 2020, CMS provided guidance permitting laboratories to use the CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel Assay for use in CDC qualified laboratories.  At that time, testing was limited to the CDC developed test and could only be performed by qualified laboratories designated by CDC and, in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests.[3] Since then, the FDA has approved a number of laboratory-developed tests being performed by private companies throughout the United States.[4]

II.   Billing for CMS:

On March 5, 2020, CMS announced new HCPCS codes for laboratories to bill Medicare for diagnostic tests for coronavirus.  There are two new HCPCS codes: U0001 and U0002.

  • U0001: This code is to be used only for the test developed by the Centers for Disease Control and Prevention (CDC) for 2019-nCoV/SARS-CoV-2.
  • U0002: This code is to be used for non-CDC developed laboratory tests for 2019-nCoV/SARS-CoV-2.

Starting April 1, 2020, Medicare claims processing systems will be able to accept these codes for dates of service on or after February 4, 2020.[5]

The following are the current COVID-19 Test Pricing as of March 12, 2020[6]:

MAC Jurisdiction (J) MAC States/Territories U0001 Test PriceU0002 Test Price
 J6 – National Government Services (NGS) Illinois, Minnesota, Wisconsin $35.91 $51.31
 JK – National Government Services (NGS)Connecticut, New York, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont $35.91 $51.31
 JH – Novitas Solutions Arkansas, Colorado, New Mexico, Oklahoma, Texas Louisiana, Mississippi $35.92 $51.33
 JL – Novitas Solutions Delaware, District of Columbia, Maryland, New Jersey, Pennsylvania; Part B services include Arlington and Fairfax counties in VA, and the city of Alexandria, VA $35.92 $51.33
 JN – First Coast Service Options (FCSO) Florida, Puerto Rico, U.S. Virgin Islands $35.92 $51.33
 JM–Palmetto Government Benefits Administrators (PGBA)North Carolina, South Carolina, Virginia, West Virginia $35.91 $51.31
 JE – Noridian Healthcare Solutions California, Hawaii, Nevada, American Samoa, Guam, Northern Mariana Islands $35.91 $51.31
 JF – Noridian Healthcare SolutionsAlaska, Arizona, Idaho, Montana, North Dakota, Oregon, South Dakota, Utah, Washington, Wyoming $35.91 $51.31
 J5 – Wisconsin Physician Services (WPS) Iowa, Kansas, Missouri, Nebraska $35.92 $51.31
 J8 – Wisconsin Physician Services (WPS) Indiana, Michigan $35.92 $51.31
J15 – CGSKentucky, Ohio$35.92$51.31
JJ–Palmetto Government Benefits Administrators (PGBA) Alabama, Georgia, Tennessee $35.91 $51.31
 JM–Palmetto Government Benefits Administrators (PGBA)North Carolina, South Carolina, Virginia, West Virginia $35.91 $51.31
 JE – Noridian Healthcare Solutions California, Hawaii, Nevada, American Samoa, Guam, Northern Mariana Islands $35.91 $51.31
 JF – Noridian Healthcare SolutionsAlaska, Arizona, Idaho, Montana, North Dakota, Oregon, South Dakota, Utah, Washington, Wyoming $35.91 $51.31
 J5 – Wisconsin Physician Services (WPS) Iowa, Kansas, Missouri, Nebraska $35.92 $51.31
J8 – Wisconsin Physician Services (WPS) Indiana, Michigan $35.92 $51.31
J15 – CGSKentucky, Ohio$35.92$51.31

On March 31, 2020, CMS published new specimen collection codes for laboratories billing for COVID-19 testing.  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:

  • 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.

These codes are billable by clinical diagnostic laboratories. (See MLN Connects, “COVID-19: Regulatory Changes, Telehealth Billing, and Specimen Collection Codes.” Published March 31, 2020).

III.   Billing for COVID-19 Diagnostic Testing to Private Payors:

Private payors are also taking measures to encourage COVID-19 diagnostic testing of their beneficiaries.  The following are the measures taken by five of the largest national payors in relation to COVID-19 diagnostic testing.[7]

  • Aetna[8]
    • Aetna will waive co-pays for all diagnostic testing related to COVID-19.
  • Anthem[9]
    • Anthem will cover the cost of coronavirus testing with no out-of-pocket cost.
    • Anthem also confirms that prior authorization is not required for diagnostic services related to COVID-19 testing.
    • Anthem’s affiliated plans will continue to waive copays, coinsurance and deductibles for diagnostic tests for COVID-19, and extending this to include waiver of copays, coinsurance, and deductibles for visits associated with in-network COVID-19 testing, whether the care is received in a doctor’s office, urgent care center or emergency department.
  • Blue Cross Blue Shield (General Association)[10]
    • BCBS announced that its network of 36 independent and locally operated companies will:
      • waive prior authorizations for diagnostic tests and covered services for COVID-19, and
      • cover those tests at no cost share to members.
    • This applies to fully insured, individual, and Medicare Advantage plan members, and plans are working with state Medicaid and CHIP agencies to ensure people have access to needed testing and services.
  • Cigna[11]
    • Cigna is covering the cost of coronavirus testing and waiving all co-pays or cost-shares for fully insured plans, including employer-provided coverage, Medicare Advantage, Medicaid, and individual market plans available through the Affordable Care Act.
    • Cigna also announced it will waive customers’ out-of-pocket costs for COVID-19 testing-related visits with in-network providers, whether at a doctor’s office, urgent care clinic, emergency room or via telehealth, through May 31, 2020.
  • UnitedHealthcare[12]
    • UHC is waiving costs for COVID-19 testing provided at approved locations in accordance with the CDC guidelines, as well as waiving copays, coinsurance and deductibles for visits associated with COVID-19 testing.
    • This coverage is not dependent on whether the care is received in a physician’s office, an urgent care center or an emergency department.
    • This coverage applies to Medicare Advantage and Medicaid members as well as commercial members.
    • UHC is also expanding provider telehealth access and waiving member cost sharing for COVID-19 testing-related visits.

IV.   Conclusion:

Liles Parker attorneys and staff are closely monitoring HHS, CMS and CDC guidance and will update this article as new information becomes available. Please contact us with questions or for assistance with your response to this unprecedented National Emergency.

COVID-19 TestingMary Soule Culter is an Associate Attorney at Liles Parker’s Washington, DC office.  She focuses her practice on regulatory health care compliance matters, fraud and abuse, and reimbursement issues. Questions regarding the Lab Testing Guidance for COVID-19?  Call Liles Parker, PLLC for a free consultation.  We can be reached at:  1 (800) 465-1906.

[1] Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak, Issued on March 13, 2020, available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.

[2] Determination that a Public Health Emergency Exists, issued by Secretary Azar on January 31, 2020, available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.

[3] CMS, “Notification to Surveyors of the Authorization for Emergency Use of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel Assay and Guidance for Authorized Laboratories,” available at https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and-memos-states-and/notification-surveyors-authorization-emergency-use-cdc-2019-novel-coronavirus-2019-ncov-real-time-rt.

[4] Readers can monitor the list of FDA Emergency Use Authorizations for SARS-CoV-2 tests on the FDA’s website available at: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations.

[5] CMS, “Press Release: CMS Develops Additional Code for Coronavirus Lab Tests”, available at https://www.cms.gov/newsroom/press-releases/cms-develops-additional-code-coronavirus-lab-tests.

[6] CMS, “Fact Sheet: Medicare Administrative Contractor (MAC) COVID-19 Test Pricing (PDF)”, available at https://www.cms.gov/files/document/mac-covid-19-test-pricing.pdf.

[7] Visit America’s Health Insurance Plans’ (AHIP) website for more payors’ plans related to COVID-19 diagnostic testing.  See AHIP, “Health Insurance Providers Respond to Coronavirus (COVID-19)”, available at https://www.ahip.org/health-insurance-providers-respond-to-coronavirus-covid-19/?fbclid=IwAR019orl2bXznUeWbmrldExyyrdt-dZ614xaowUgoc9IHXsOg0efo-iAwoA.

[8] CVS Health, “CVS Health announces COVID-19 resources for Aetna members”, available at https://cvshealth.com/newsroom/press-releases/cvs-health-announces-covid-19-resources-aetna-members.

[9] Anthem, “Anthem Issues Updates Regarding COVID-19 Testing and Care to Support Affiliated Health Plan Members”, available at https://ir.antheminc.com/news-releases/news-release-details/anthem-issues-updates-regarding-covid-19-testing-and-care?field_nir_news_date_value[min]=.

[10] BlueCross BlueShield, “Blue Cross and Blue Shield Companies Announce Coverage of Coronavirus Testing for Members and Other Steps to Expand Access to Coronavirus Care”, available at https://www.bcbs.com/press-releases/blue-cross-and-blue-shield-companies-announce-coverage-of-coronavirus-testing.

[11] Cigna, “Cigna Covers Cost Of Coronavirus Tests For Customers”, available at https://www.cigna.com/newsroom/news-releases/2020/cigna-covers-cost-of-coronavirus-tests-for-customers.

[12] UnitedHealthcare, “UnitedHealthcare Expands Access to Care, Support and Resources to Help People and Families Address COVID-19”, available at https://newsroom.uhc.com/news-releases/UnitedHealthcare-COVID-19.html.

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