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COVID-19 Laboratory Resource Center

During these turbulent times, COVID-19 information is changing quickly. XIFIN is committed to helping laboratories and diagnostics providers obtain the information they need, including the latest on testing, testing supply needs, and payor billing requirements.
Updated 9/13/21 11:10 AM PDT

Lab Volume Index

The Lab Volume Index synthesizes billing volume data into a measurement of testing volumes as compared to a pre-Coronavirus testing average ("baseline"). XIFIN analyzed its vast stores of data, representative of four out of five top integrated delivery networks (IDNs) and seven out of the top ten independent laboratories nationwide, to craft the Lab Volume Index.

View Index

COVID-19 Test Billing Updates

With information changing frequently, XIFIN is in daily discussions with each of the major payors, to confirm billing code assignment, any billing specific requirements, and reimbursement information. We will continue to provide live updates as we receive them.

Jan 6 2021 |  CDC/HCHS Implementing Additional Codes in Response to COVID-19

As a result of the ongoing COVID-19 public health emergency, the Centers for Disease Control and Prevention’s National Center for Health Statistics (CDC/NCHS) is implementing additional codes into the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) for reporting to include:

  • Encounter for screening for COVID-19 (Z11.52)
  • Contact with and (suspected) exposure to COVID-19 (Z20.822)
  • Personal history of COVID-19 (Z86.16)
  • Multisystem inflammatory syndrome (MIS) (M35.81)
  • Other specified systemic involvement of connective tissue (M35.89)
  • Pneumonia due to coronavirus disease 2019 (J12.82)

These new codes will be effective January 1, 2021 to identify conditions resulting from COVID-19.

Reference: https://www.cdc.gov/nchs/data/icd/Announcement-New-ICD-code-for-coronavirus-19-508.pdf

 

Jan 1 2021 |  CMS Amended Administrative Ruling CMS-2020-1-R2

CMS has amended Administrative Ruling CMS-2020-1-R2, which provides coding guidelines for the new U0005 code and testing speed-driven reimbursement rates for high throughput COVID testing. 

As required by the HCPCS code U0005 descriptor, the majority of a laboratory’s CDLTs making use of high throughput technologies for the detection of SARS-CoV2 or the diagnosis of the virus that causes COVID-19 for all patients (including non-Medicare patients) in the previous calendar month have to be completed in 2 calendar days or less from the date the specimen was collected. More specifically, laboratories would assess the timeliness of those tests in the month preceding the month identified by the line date of service for the corresponding CDLT (represented by HCPCS U0003 or U0004). In the circumstance that the laboratory has not completed 51% of its CDLTs making use of high throughput technologies for the detection of SARS-CoV-2 or the diagnosis of the virus that causes COVID-19 (for all patients) in 2 calendar days from the date the specimen was collected during the applicable month, it may not bill for HCPCS code U0005 with HCPCS codes U0003 or U0004. For example, a laboratory is submitting a claim to Medicare for a CDLT performed on high throughput technology for the detection of SARS-CoV-2 or the diagnosis of the virus that causes COVID-19 using HCPCS code U0003 with a line date of service of May 15, 2021. This laboratory would assess its performance based on CDLTs making use of high throughput technologies for the detection of SARS-CoV-2 or the diagnosis of the virus that causes COVID19 completed during the calendar month (April 1, 2021 – April 30, 2021) that precedes the month identified by the CDLT line date of service (May 2021). If the laboratory completed a total of 1000 of those CDLTs (including all such tests for non-Medicare patients) in April, and 490 of them had been completed within 2 calendar days of the specimen being collected, the laboratory would have a 49% test timeliness completion rate and may not bill for the $25 add-on payment as represented by HCPCS code U0005.

Source: https://www.cms.gov/files/document/cms-ruling-2020-1-r2.pdf

FAQ (high throughput specific FAQs begin on page 12): https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf

Nov 10, 2020 |  Additional CPT Code Added for COVID-19 multiplex immunoassay antigen testing 87428

The CPT Editorial Panel has approved a new code to describe multiplex immunoassay antigen testing for three viral targets, ie, SARS-CoV, SARS-CoV-2 [COVID-19], and influenza virus types A and B for immediate use. Changes were published on Tuesday, November 10, 2020. See AMA's CPT Assistance November Update.

Oct 28, 2020 |  CMS Releases Interim Final Rule for COVID-19 Price Transparency

On October 28, 2020, the Centers for Medicare and Medicaid Services (CMS) released a pre-publication copy of an Interim Final Rule with Comment Period (IFC) that includes a section entitled “Price Transparency for COVID-19 Diagnostic Tests.” It implements the section of the CARES Act that requires each provider of a diagnostic test for COVID-19 to publicize cash prices for such testing
on the provider’s website during the Public Health Emergency and imposes civil monetary penalties of $300/day for non-compliance. The IFC is effective immediately, 

Source: https://www.cms.gov/newsroom/fact-sheets/fourth-covid-19-interim-final-rule-comment-period-ifc-4

Complete IFC document: https://www.cms.gov/files/document/covid-vax-ifc-4.pdf

More about the Coverage Transparency Rule: https://www.cms.gov/newsroom/fact-sheets/transparency-coverage-final-rule-fact-sheet-cms-9915-f#_ftn1

Questions about compliance can be directed to: COVID19CashPrice@cms.hhs.gov

NEW Oct 15, 2020 |  CMS Changes Medicare Payment to Support Faster COVID-19 Diagnostic Testing

CMS is announcing that starting January 1, 2021, Medicare will pay $100 only to laboratories that complete high throughput COVID-19 diagnostic tests within two calendar days of the specimen being collected.  Also effective January 1, 2021, for laboratories that take longer than two days to complete these tests, Medicare will pay a rate of $75. CMS is working to ensure that patients who test positive for the virus are alerted quickly so they can self-isolate and receive medical treatment.

Source:  CMS Changes Medicare Payment to Support Faster COVID-19 Diagnostic Testing

NEW Oct 7, 2020 |  Two New CPT Codes Added for COVID-19 Multi Virus Tests: 87636 and 87637

The CPT Editorial Panel approved two new Category I codes for immediate use, and also revised codes to remove the undefined term "multi step moethod" from code descriptors, and published these changes on Wednesday, October 7, 2020. For a list of the new and revised codes specific to laboratory testing for SARS-CoV-2 and the new and revised parenthetical notes and guidelines to correct and clarify reporting of infectious agent antigen studies, see AMA's CPT Assistance October Update.

For quick reference, the new category I CPT codes and long descriptors are:

87636 Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) and influenza virus types A and B, multiplex amplified probe technique

87637 Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), influenza virus types A and B, and respiratory syncytial virus, multiplex amplified probe technique

The CPT Editorial Panel also revised CPT codes ranging from 87301 to 87430 by removing the undefined term “multi step method” from code descriptors. The revision clarifies the proper reporting for antigen tests that are read by a machine, as compared to those which can be visually interpreted without a machine. This revision affects the newly developed descriptor for CPT code 87426.

87426 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])

In accordance with the above revision, the CPT Editorial Panel approved a new category I code, 87811, to report infectious agent antigen detection by immunoassay with direct visual observation.

87811 Infectious agent antigen detection by immunoassay with direct optical (ie, visual) observation; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19])

Source: New CPT codes for multi-virus tests detect COVID-19 and flu

UPDATED Sep 8, 2020 |  Two New CPT Codes Added for COVID-19: 86413 and 99072

The CPT Editorial Panel approved two new Category I codes and expedited the publication of these new codes to the AMA website on Tuesday, September 8, 2020, at https://www.ama-assn.org/delivering-care/public-health/covid-19-2019-novel-coronavirus-resource-center-physicians These codes are effective immediately.

CPT code 86413: established to report quantitative antibody detection for SARS-CoV-2.

CPT code 99072: established to report additional practice expenses incurred during a Public Health Emergency, including supplies and additional clinical staff time. It represents a new practice expense code specifically intended for use during a declared Public Health Emergency as defined by law, due to respiratory-transmitted infectious disease. This new code is established in response to the significant additional practice expenses related to activities required to safely provide medical services to patients in person during such an emergency over and above those usually included in a medical visit or service. This code should only be reported when the service is rendered in a non-facility place of service (POS) setting, and in an area where it is required to mitigate the transmission of the respiratory disease for which the PHE was declared.

 

 

Aug 10, 2020 |  Four New CPT Codes Added for COVID-19: 86408, 86409, 0225U, 0226U86413 and 99072

The CPT Editorial Panel approved four new codes and expedited the publication of these new codes to the AMA website on Monday, August 10, 2020. These codes are effective immediately.

CPT code 86408 NEUTRALIZING ANTIBODY SARS-COV-2 SCREEN.

CPT code 86409 NEUTRALIZING ANTIBODY SARS-COV-2 TITER

CPT code 0225U NFCT DS DNA&RNA 21 TARGETS SARSCOV-2 AMP PROBE

Code 0226U SUROGAT VIR NEUTRLZJ TST SARSCOV2 ELISA PLSM SRM

For more information: AMA Code Assist August Update

UPDATED Jul 30, 2020 |  CMS Modifies Relaxed Billing Reqts for COVID-19 Laboratory Tests, Adds CPT 87426

During the COVID-19 Public Health Emergency (PHE), CMS relaxed requirements for a limited number of laboratory tests required for a COVID-19 diagnosis. These tests do not require a practitioner order during the PHE. CMS added a new test to this list: CPT 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]).

Any health care professional authorized under state law may order these tests. Medicare will pay for these tests without a written order from the treating physician or other practitioner:

  • If an order is not written, you do not need to provide the National Provider Identifier (NPI) of the ordering or referring professional on the claim
  • If an order is written, include the NPI of the ordering or referring professional, consistent with current billing guidelines

MLN Matters Article on Code 87426

List of Laboratory Tests andf Modified Requirements

Interim Final Rule

July 15, 2020 | Updated 7/17: Hospitals Ordered to Bypass CDC for COVID Data Reporting

The Trump administration has ordered hospitals to bypass the Centers for Disease Control and Prevention and send all Covid-19 patient information to a central database in Washington beginning on Wednesday, July 15, 2020. As stated in a COVID Guidance for Hospital Reporting document posted on the HHS website, "As of July 15, 2020, hospitals should no longer report the Covid-19 information in this document to the National Healthcare Safety Network site." Concerns have been expressed about data transparency, and on July 17, a letter signed by more than 100 organizations was sent to Vice President Pence, Ambassador Birx and Secretary Azar recommending that the administration immediately reverse its decision to bypass the Centers for Disease Control and Prevention (CDC) for data collection.  

Resources:

COVID-19 Guidance for Hospital Reporting and FAQs For Hospitals, Hospital Laboratory, and Acute Care Facility Data Reporting

Trump Administration Strips CDC of Control of Coronavirus Data, NYTimes

Jun 26, 2020 |  AMA Unveils New Category I CPT 87426 for COVID-related Antigen Testing

In its announcement, the American Medical Association (AMA) stated that the new code is meant for “use as the industry standard for accurate reporting and tracking of antigen tests using immunofluorescent or immunochromatographic technique for the detection of biomolecules produced by the SAR-CoV-2 virus.” 

Resources:

AMA Announcement

RevCycleIntelligence article with additional background and information about descriptors

Jun 4, 2020 |  HHS Stipulates Additional Reporting of Demographic Data for COVID Testing

New federal guidance released today indicates labs will be required to submit a much broader range of demographic COVID-19 testing data, including age, race, ethnicity, sex, patient zip code, type of test performed and the test's result. By August 1, all labs must be able to submit the new data fields to relevant state and local health departments within 24 hours of the results being determined to help with COVID-19 tracking, contact tracing, supply allocation and research. De-identified data will then be sent to the Centers for Disease Control and Prevention on a daily basis. Labs will not be required to report retroactive data. 

Labs can report through three electronic mechanisms: directly to state and local governments through existing channels, which will then get de-identified data to the CDC; through a centralized platform, such as the Association of Public Health Labs' AIMS platform, which routes the data to appropriate state and local government and the CDC; and through state and regional health information exchanges.

During the briefing, Admiral Brett Giroir, M.D., assistant secretary for health and lead for COVID-19 testing efforts, added that labs (not manufacturers or distributors) that fail to report the required data could face penalties, enforced by the FDA under Emergency Use Authorization. Penalties could take the form of warning letters or fines, or – in extreme cases – imprisonment.

Resources:

Laboratory Data Reporting Guidance

Laboratory Data Reporting FAQ

May 19, 2020 |  CMS Publishes MAC COVID-19 Test Pricing

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. See the Medicare tab in the Payor Information and Updates section, below.

May 14, 2020 |  OIG Updates its COVID-19 FAQs

FAQs address application of OIG's Administrative Enforcement Authorities to arrangements directly connected to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.  

https://oig.hhs.gov/coronavirus/authorities-faq.asp

April 30, 2020 | HRSA COVID-19 Uninsured Program Portal Is Now Open

The Health Resources and Services Administration has opened its COVID-19 Uninsured Program Portal, which provides additional information as well as the ability for providers to register.  A recorded webinar is available: Getting Started with the HRSA COVID-19 Uninsured Program 

Please note the program timelines:

•    April 22 – Program Details launch
•    April 27 – Sign up period begins for the program
•    April 29 – On Demand training starts
•    May 6 – Begin submitting claims electronically
•    Mid-May – Begin receiving reimbursement

Program FAQs

April 26, 2020 | CMS Reevaluates Accelerated Payment Program and Suspends Advance Payment Program 

On April 26, the Centers for Medicare & Medicaid Services (CMS) announced that it is reevaluating the amounts that will be paid under its Accelerated Payment Program and suspending its Advance Payment Program to Part B suppliers effective immediately. The agency made this announcement following the successful payment of over $100 billion to health care providers and suppliers through these programs and in light of the $175 billion recently appropriated for health care provider relief payments.

CMS had expanded these temporary loan programs to ensure providers and suppliers had the resources needed to combat the beginning stages of the 2019 Novel Coronavirus (COVID-19). Funding will continue to be available to hospitals and other health care providers on the front lines of the coronavirus response primarily from the Provider Relief Fund

CMS Press Release: https://www.cms.gov/newsroom/press-releases/cms-reevaluates-accelerated-payment-program-and-suspends-advance-payment-program

For an updated fact sheet on the Accelerated and Advance Payment Programs, visit:https://www.cms.gov/files/document/Accelerated-and-Advanced-Payments-Fact-Sheet.pdf

April 15, 2020 | CMS Announces Increased Payments for COVID-19 Testing, Introduces Two New Codes 

Today CMS announced Medicare will nearly double payment for certain lab tests that use high-throughput technologies to rapidly diagnose large numbers of 2019 Novel Coronavirus (COVID-19) cases. Medicare will pay laboratories for the tests at $100 effective April 14, 2020, through the duration of the COVID-19 national emergency. 

More information can be found on the Medicare tab, below.

CMS Press Release: https://www.cms.gov/newsroom/press-releases/cms-increases-medicare-payment-high-production-coronavirus-lab-tests-0

ACLA commentary: https://www.acla.com/cms-takes-decisive-action-to-support-laboratories-responding-to-covid-19-pandemic/

April 13, 2020 | Expanded Coverage Announced for Essential Diagnostic Services for COVID Testing, Including Antibody Testing, and Certain Related Services without Cost Sharing for Enrollees in Private Health Coverage

Specifically, today’s announcement implements the requirement for group health plans and group and individual health insurance to cover both diagnostic testing and certain related items and services provided during a medical visit with no cost sharing. This includes urgent care visits, emergency room visits, and in-person or telehealth visits to the doctor’s office that result in an order for or administration of a COVID-19 test. Covered COVID-19 tests include all FDA-authorized COVID-19 diagnostic tests, COVID-19 diagnostic tests that developers request authorization for on an emergency basis, and COVID-19 diagnostic tests developed in and authorized by states. It also ensures that COVID-19 antibody testing will also be covered. 

To see the guidance, visit: https://www.cms.gov/files/document/FFCRA-Part-42-FAQs.pdf

April 13, 2020 | AMA CPT Editorial Panel had an emergency meeting on Friday, April 10, 2020, and expedited two new CPT codes for the COVID-19 Antibody Tests
  • 86328 Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single step method (eg, 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] 

https://www.ama-assn.org/press-center/press-releases/ama-announces-expedited-updates-cpt-covid-19-antibody-tests

AMA also published a Special Edition of the CPT Assistant: SARS-CoV-2 Serologic Laboratory Testing, which provides additional guidance on how to code the two new antibody tests for COVID-19. https://www.ama-assn.org/system/files/2020-04/cpt-assistant-guide-coronavirus-april-2020.pdf 

March 31, 2020 | CMS Releases Waivers for COVID-19

The waivers apply nationwide and are retroactive to March 1, 2020. The American Hospital Association has provided its take and a summary of the waivers, accessible here

COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers
Relevant information for laboratories begins on p. 18: https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf

Waivers regarding the Stark Law
https://www.cms.gov/files/document/covid-19-blanket-waivers-section-1877g.pdf

March 31, 2020 | CMS Issues New HCPC Codes

New Specimen Collection Codes for Laboratories Billing for COVID-19 Testing--see Medicare tab below for details.

May 29, 2020 | Hospital Labs: Report Your Results to FEMA

Vice President Pence sent a letter to hospital administrators requiring laboratories performing testing for SARS-CoV-2 to report their in-house test results in aggregate via an email to FEMA. Hospitals do NOT need to report testing sent to specific commercial labs. See this link for the contents of the letter. You can access the spreadsheet template, here.

Payor Information and Updates

Updated 4/21/20

Payor COVID-19 Billing Guidelines Acceptable CPT Code(s)/HCPCS Code(s)
View Guidelines U0001, U0002, 87635
Click on BCBS tab for info Click on BCBS tab for info

Cigna updated its Medical Coverage Policy for COVID-19 Diagnostic Testing with medically necessary and not medically necessary explanation.

COVID-19: In Vitro Diagnostic Testing

Cigna's  Response to COVID-19

RE U0005: making use of high throughput technologies, completed within 2 calendar days from date and time of specimen collection. (List separately in addition to either HCPCS code U0003 or U0004) (Code effective 01/01/2021).

View Guidelines

Diagnostic COVID-19 related laboratory tests (other than COVID-19 test) 

  • For other laboratory tests when COVID-19 may be suspected
  • Cost-share will be waived
  • Paid per contract

U0001, U0002, U0003, U0004, 87635, 86328 , 86769, G2023, G2024

1-6-21: 

The Humana Claims Payment Policy for COVID-19 Related Coding (Policy Number: CP2020001) was recently revised with inclusion of U0005. 

 

HCPCS code U0005 is only reported in conjunction with either HCPCS code U0003 or U0004. All applicable requirements CMS has established for the billing of HCPCS code U0005 must be met.

View Guidelines

When testing patients for other viral respiratory conditions to rule out COVID-19, select the most appropriate code for the test performed.

    Molecular: U0001, U0002, U0003, U0004, 87635, 0202U, 0223U, 0225U, 87636, 87637, 0350U, 0241U, U0005

    Antibody: 86328, 86769, 0224U, 86408, 86409, 0226U, 86413

    Antigen: 87426, 87811, 87428

    The following CPT codes are accepted for other viral testing to rule out COVID-19:

    • CPT 87804 – Infectious agent antigen detection by immunoassay with direct optical observation; influenza
    • CPT 87633 – Respiratory virus panel [Infectious agent detection by nucleic acid (DNA or RNA)]
    • CPT 87486 – C. pneumoniae [Infectious agent detection by nucleic acid (DNA or RNA)]
    • CPT 87581 – M. pneumonia [Infectious agent detection by nucleic acid (DNA or RNA)]

    The applicable COVID-19-related ICD-10 code, or code combination, as appropriate for the date of service, must also be reported on the claim.

    1-8-21: UHC updated its Claim Coding, Submissions and Reimbursement for COVID-19 testing, to add U0005. 

    This code should be used when billing for add-on payment to laboratories for a COVID-19 diagnostic test run on high throughput technology if the laboratory a) completes the test in 2 calendar days or less, and b) completes the majority of their COVID-19 diagnostic tests that use high throughput technology in 2 calendar days or less for all of their patients (not just their Medicare patients) in the previous month.

    *Effective dates of codes were determined by reference to CMS Ruling No. (CMS-2020-01-R).

     

    11-30-20 Test Registry Protocol Delayed to January 1, 2022. In response to the COVID-19 public health emergency, we are delaying implementation of the Laboratory Test Registry Protocol to January 1, 2022. To ensure compliance with these requirements, free standing and outpatient hospital lab providers should register their laboratory tests prior to December 1, 2021.

    Effective Jan. 1, 2022, claims for most laboratory test services must contain your laboratory’s unique test code for each service. Additionally, each test code submitted on a claim must match a corresponding laboratory test registration provided in advance to us, or we will deny the claim. To ensure compliance with these requirements, free standing and outpatient hospital lab providers should register their laboratory tests prior to December 1, 2021.

    These requirements apply to most UnitedHealthcare Commercial, Medicare Advantage and UnitedHealthcare Community Plan networks.

    View Guidelines

    UHC accelerated payments program information can be found here

    U0001, U0002, 87635

    Updated 1/15/21, except as explicitly marked below

    Blue Cross Blue Shield State COVID-19 Billing Guidelines Acceptable CPT Code(s)/HCPCS Code(s)
    Alabama

    View Guidelines

    86328, 86413, 86769, 87426, 87635, 87811, 0224U, C9803, G2023, G2024, U0001, U0002, U0003, U0004
    Alaska

    View Premera Guidelines

    86328, 86769, 87635, U0001, U0002, U0003, U0004
    Arizona

    View Guidelines

    86328, 86769, 87426, 87635, C9803, G2023, G2024, U0001, U0002, U0003, U0004
    Arkansas

    View Guidelines

    87635
    California

    View Anthem Guidelines

    U0001, U0002, U0003, U0004,  86328 , 86769, 87635
    California

    Blue Shield of California Screening Test for Asymptomatic Essential Workers

    How the patient may present and request a test

    • No provider order is needed for an asymptomatic self-identified essential worker screening test; however, the asymptomatic essential
    • Worker must contact Blue Shield to ask for direction to an in-network provider before making their appointment for a screening test.
    • It is the responsibility of Blue Shield to ensure that an appointment for testing is made available to these members within 48 hours of the
    • request and within 15 miles or 30 minutes of either the individual’s home or workplace.
    • If an in-network provider appointment is not available in accordance with that criteria, the member can seek testing at any site in or
    • outside of the network.
    • Workers will need to attest to the provider that they are an essential worker as specified on the DMHC’s website: essential worker.
    • Further information for members and test site locations are posted on Blue Shield’s COVID-19 member website.

    Coding and billing for a COVID-19 screening test for an asymptomatic essential worker

    • The lab or collector should use the diagnosis code Z02.79: Encounter for issue of another medical certificate.
    • 87635-32 is the code for an RT-PCR or LAMP laboratory testing.
    • 87426-32 is the code for an antigen or other diagnostic rapid point of care test.
    • The -32 modifier signifies mandated services according to the DMHC regulation published July 17, 2020.
    • Use of the -32 modifier is needed to differentiate from non-essential worker screening tests; asymptomatic non-essential worker screening testing is not a covered benefit.

    To avoid denials:

    • Do not use Z11.59: Encounter for screening for other viral diseases. Using this code for this type of claim may result in an initial denial of your claim.

    Member financial responsibility for this type of test

    • Asymptomatic essential worker screening tests are covered only for members enrolled in fully insured commercial plans (individual and family, small group, and large group). Members who receive asymptomatic essential worker screening tests are responsible for copayments, coinsurance, and deductibles when receiving this test.
    • Asymptomatic testing (for essential workers* or other enrollees) generally is not covered for self-funded plans [administrative services only (ASO) plans]Medicare, Medi-Cal, or Cal MediConnect plans, except as outlined below under COVID-19 diagnostic testing when known or suspected exposure has occurred and Pre-procedural COVID-19 diagnostic testing.

    Delegated provider financial responsibility for this type of test

    • In accordance with the DMHC emergency regulation published July 17, 2020, Blue Shield will retain financial responsibility for coverage of all COVID-19 asymptomatic essential worker testing. All delegated providers and labs should bill Blue Shield directly for specimen collection, handling, and testing processes for these tests for Blue Shield commercial HMO members.

    Pooled Testing

    At this time, pooled testing is at the sole discretion of the laboratory, is not widely being used, and is not available based by a provider’s order or employer’s request. When performed, it is billed, reported, and covered as though it is an individual test.

    View BS of CA Guidelines

    86328, 86769, 87426, 87635, 0224U, C9803, G2023, G2024, Modifier 32
    Colorado

    View Guidelines

    U0001, U0002, U0003, U0004,  86328 , 86769, 87635
    Connecticut

    View Guidelines

    U0001, U0002, U0003, U0004,  86328 , 86769, 87635
    Delaware

    View Guidelines

    U0001, U0002, U0003, U0004, 86328 , 86769, 87635, G2023, G2024 
    District of Columbia

    View Guidelines

    87635, 0240U, 87636, 0241U, 87637, U0003, U0004, 86328, 86769, 87426, 87811, 0225U
    Florida

    View Guidelines

    86328, 86408, 86409, 86769, 87635, 87426, 0202U, 0223U, 0224U, 0226U, C9803, G2023, G2024, U0002, U0003, U0004
    Georgia

    View Guidelines

    U0001, U0002, U0003, U0004,  86328 , 86769, 87635
    Hawaii

    View Guidelines

    86328, 86769, 87426, 87811, 87428, 87635, 87636, 87637, 0240U, 0241U, C9803, G2023, G2024, U0001, U0002, U0003, U0004
    Idaho

    View Guidelines

    86328, 86408, 86409, 86769, 87426, 87635, 87636, 87637, 87811, 0202U, 0223U, 0224U, 0225U, 0226U, G2023, G2024, U0002, U0003, U0004 
    Illinois

    View Guidelines

    86318, 86328, 86408, 86409, 86413, 86769, 87426, 87428, 87635, 87636, 87637, 87811, 0202U, 0223U, 0224U, 0225U, 0226U, 0240U, 0241U, C9803, G2023, G2024, U0001, U0002, U0003, U0004, CS Modifier
    Indiana

    View Guidelines

     86328, 86769, 87635, U0001, U0002, U0003, U0004
    Iowa View Guidelines 86318, 86328, 86769, 87426, 87428, 87635, 87636, 87637, 87811, v0202U, 0223U, 0224U, 0240U, 0241U, C9803, G2023, G2024, U0001, U0002, U0003, U0004, CS Modifier
    Kansas

    View Guidelines

    View Nucleic Acid Testing Guidelines

    View Specimen Code Info

    View Rapid Detection Info

    86318, 86328, 86408, 86409, 86769, 87301, 87635, 87426, 0202U, 0223U,  0224U, 0225U, 0226U, C9803, G2023, G2024, U0001, U0002, U0003, U0004
    Kentucky View Guidelines  86328, 86769, 87635, U0001, U0002, U0003, U0004
    Louisiana View Guidelines 86328, 86769, 87426, 0202U, 0223U, U0002, U0003, U0004
    Maine View Guidelines  86328, 86769, 87635, U0001, U0002, U0003, U0004
    Maryland View Guidelines 86328, 86769, 87426, 87635, 87636, 87637, 87811, 0225U, 0240U, 0241U , U0002, U0003, U0004
    Massachusetts

    Blue Cross Massachusets Guidelines

    Blue Cross Massachusets Temporary Payment Policy

    87635, C9803, G2023, G2024, U0001, U0002, U0003, U0004, CS Modifier
    Michigan

    View Guidelines

    View recommendations

    View drive through recommendations

    87635, G2023, U0001, U0002, U0003, U0004
    Minnesota

    BCBS Minnesota has added U0005 as an acceptable add-on code for COVID-19 testing:

    U0005 – Add-on code to U0003, when the lab

    • completes the test in two calendar days or less, and
    • b) completes the majority of their COVID-19 diagnostic tests that use high throughput technology in two calendar days or less for all of their patients (not just their Medicare patients) in the previous month. (Effective 1/1/2021)

    View Guidelines

    86328, 86413, 86769, 87426, 87428, 87635, 87636, 87637, 87811, 0202U, 0223U, 0224U, 0225U, 0240U, 0241U, C9803, G2023, G2024, U0001, U0002, U0003, U0004, U0005, CS Modifier

     

    • HCPCS U0001: $35.91 – effective 2/4/20 dates of service
    • HCPCS U0002: $51.31 – effective 2/4/20 dates of service
    • HCPCS U0003: $100.00 – effective 4/14/20 through 12/31/20 dates of service
    • HCPCS U0003: $75.00 – effective 1/1/21 dates of service
    • HCPCS U0004: $100.00 – effective 4/14/20 dates of service
    • HCPCS U0005: $25.00 – effective 1/1/21 dates of service
    Mississippi

    BCBS of Mississippi added U0005:

    View Guidelines

    86328, 86408, 86409, 86413, 86769, 87426, 87428, 87635, 87636, 87637, 87811, 0202U, 0223U, 0224U, 0225U, 0226U, 0240U, 0241U, C9803, G2023, G2024, U0001, U0002, U0003, U0004, U0005, 
    Missouri View Anthem Blue Cross and BLue Shield MO Guidelines  86328, 86769, 87635, U0001, U0002, U0003, U0004
    Missouri View Blue KC Guidelines U0001, U0002, 86328 , 86769, 87635
    Montana View Guidelines 86318, 86328, 86408, 86409, 86413, 86769, 87426, 87428, 87635, 87636, 87637, 87811, 0202U, 0223U, 0224U, 0225U, 0226U, 0240U, 0241U, C9803, G2023, G2024, U0001, U0002, U0003, U0004, CS Modifier
    Nebraska

    BCBS Nebraska has added U0005 as an add-on code for COVID-19 testing.

    View Guidelines

    86328, 86408, 86409, 86769, 87635, U0001, U0002, U0003, U0004, U0005
    Nevada View Guidelines  86328, 86769, 87635, U0001, U0002, U0003, U0004
    New Hampshire View Guidelines  86328, 86769, 87635, U0001, U0002, U0003, U0004
    New Jersey

    Horizon BCBS New Jersey added U0005 to its reimbursement policy.

    Horizon Announcement

    Horizon Policy

    Reimbursement Policy effective January 1, 2021: Add-on Payment for COVID-19 Diagnostic Testing Run on High Throughput Technology (U0005)

    Our new reimbursement policy, Add-on Payment for COVID-19 Diagnostic Testing Run on High Throughput Technology (U0005), will be effective January 1, 2021. This policy aligns with the Centers for Medicare & Medicaid Services’ approach.

    Effective January 1, 2021, and throughout the period of the COVID-19 public health emergency as declared by the Governor of New Jersey, we will:

    • Consider an additional add-on payment (U0005) of $25 for COVID-19 diagnostic testing run on high throughput technology, when billed with procedure code U0003 or U0004, and when the following conditions are met:
      1. Procedure codes U0003 or U0004 COVID-19 testing is completed in two calendar days or less for the specific test billed, and
      2. The laboratory can certify that 51% of the previous months' U0003 and U0004 COVID-19 diagnostic testing was completed within two calendar days or less.
    • Reduce our reimbursement for U0003 and U0004 from $100 to $75.

    The clinical laboratory must maintain self-certification of the above conditions.

    Failure to adhere to the above requirements while continuing to bill U0005 shall be considered inappropriate billing with this policy and may result in add-on payments not being reimbursed.

    We reserve the right to perform post-service audits to ensure the above requirements are met and to recover reimbursement made if these requirements are not met.

    We encourage clinical laboratories to review the content of our Add-on Payment for COVID-19 Diagnostic Testing Run on High Throughput Technology (U0005) reimbursement policy.

    Horizon COVID-19 CPT Testing Codes

    U0001, U0002, U0003, U0004, U0005, 86328 , 86769, 87635, G2023, G2024, CS Modifier
    New Mexico View Guidelines 86318, 86328, 86408, 86409, 86413, 86769, 87426, 87428, 87635, 87636, 87637, 87811, 0202U, 0223U, 0224U, 0225U, 0226U, 0240U, 0241U, C9803, G2023, G2024, U0001, U0002, U0003, U0004, CS Modifier
    New York View Empire BC Guidelines  86328, 86769, 87635, U0001, U0002, U0003, U0004
    New York View Western NY Guidelines 86328, 86769, 87635, U0001, U0002  
    New York View Northeastern NY Guidelines 86328, 86769, 87635, U0001, U0002
    New York View Excellus Guidelines 86328, 87635, 86769, 0202U, G2023, G2024, U0001, U0002, U0003, U0004
    North Carolina

     

    Commencing on January 25, 2021

    Laboratories may continue to bill for the COVID-19 codes U0003 and U0004 at their typical billed rate but should expect to be reimbursed at $75 per test.  It is the expectation of the health plans that Providers will only submit claims for U0005 if their current turnaround time is within the two (2)-day limit as described by CMS.  If a Provider submits claims for U0005, please note the following:

    1. Per the agreement with Avalon, Providers may be audited to confirm compliance with the turnaround time guidelines
    2. Providers found to have exceeded the two (2)-day turnaround time will be denied payment for further claims for U0005 until such time that the Provider can demonstrate their ability to meet the turnaround time requirement
    3. Reimbursement made for previous claims that exceeded the two (2)-day turnaround time will be offset against future reimbursement due to the Provider

    View Guidelines

    View FAQ

    86328, 86408, 86409, 86413, 86769, 87426, 87428, 87635, 87636, 87637, 87811, 0202U, 0223U, 0224U, 0225U, 0226U, 0240U, 0241U, C9803, G2023, G2024, U0001, U0002, U0003, U0004, 

     

     

    U0003 and U0004 at $75 per test

    U0005: Laboratories that meet the turnaround times set forth in the CMS guidelines may file CPT code U0005 and be reimbursed the additional $25 per test. 

    North Dakota View Guidelines 86318, 86328, 86408, 86409, 86413, 86769, 87426, 87428, 87635, 87636, 87637, 87811, 0202U, 0223U, 0224U, 0225U, 0226U, 0240U, 0241U, G2023, G2024, U0001, U0002, U0003, U0004, 32, CR, CS Modifiers
    Ohio View Guidelines  86328, 86769, 87635, U0001, U0002, U0003, U0004
    Oklahoma View Guidelines 86318, 86328, 86408, 86409, 86413, 86769, 87426, 87428, 87635, 87636, 87637, 87811, 0202U, 0223U, 0224U, 0225U, 0226U, 0240U, 0241U, C9803, G2023, G2024, U0001, U0002, U0003, U0004, CS Modifier
    Oregon

    Regence COVID-19 Testing Policy

    Regence COVID-19 Treatment Policy

    86328, 86413, 86769, 87426, 87428, 87499, 87635, 87636, 87637, 87811, 0202U, 0223U, 0224U,  0225U, 0240U, 0241U, C9803, G2023, G2024, U0001, U0002, U0003, U0004
    Pennsylvania

    Commencing on January 25, 2021

    Laboratories may continue to bill for the COVID-19 codes U0003 and U0004 at their typical billed rate but should expect to be reimbursed at $75 per test.  It is the expectation of the health plans that Providers will only submit claims for U0005 if their current turnaround time is within the two (2)-day limit as described by CMS.  If a Provider submits claims for U0005, please note the following:

    1. Per the agreement with Avalon, Providers may be audited to confirm compliance with the turnaround time guidelines
    2. Providers found to have exceeded the two (2)-day turnaround time will be denied payment for further claims for U0005 until such time that the Provider can demonstrate their ability to meet the turnaround time requirement
    3. Reimbursement made for previous claims that exceeded the two (2)-day turnaround time will be offset against future reimbursement due to the Provider
    View Capital Blue Guidelines

    86328, 86769, 87635, G2023, G2024, U0001, U0002, U0003, U0004

     

     

    U0003 and U0004 at $75 per test

    U0005: Laboratories that meet the turnaround times set forth in the CMS guidelines may file CPT code U0005 and be reimbursed the additional $25 per test. 

    Pennsylvania View Highmark HBS Guidelines 86328, 86769, 87635, C9803, G2023, G2024, U0001, U0002, U0003, U0004
    Pennsylvania View Highmark BCBS Guidelines 86328, 86769, 87635, C9803, G2023, G2024, U0001, U0002, U0003, U0004
    Pennsylvania

    https://provcomm.ibx.com/ibc/news/Pages/20-2351_Testing_Update04072020.aspx

    https://provcomm.ibx.com/ibc/news/Pages/20-2454-Billing_and_coding_for_testing.aspx

    86143, 86328, 86408, 86409, 86769, 87246, 87635, 0202U, 0223U, 0224U, 0225U, 0226U, G2023, G2024, U0001, U0002, U0003, U0004
    Puerto Rico   U0001, U0002, 87635
    Rhode Island

    BCBS Rhode Island has added U0005 to its COVID-19 Payment Policy as of January 12, 2021, with an effective date of January 1, 2021.

    View Guidelines

    86328, 86408, 86409, 86413, 86769, 87426, 87428, 87635, 87636, 87637, 87811, 0202U, 0223U, 0224U, 0225U, 0226U, 0240U, 0241U, C9803, G2023, G2024, U0001, U0002, U0003, U0004, U0005
    South Carolina

    Commencing on January 25, 2021

    Laboratories may continue to bill for the COVID-19 codes U0003 and U0004 at their typical billed rate but should expect to be reimbursed at $75 per test.  It is the expectation of the health plans that Providers will only submit claims for U0005 if their current turnaround time is within the two (2)-day limit as described by CMS.  If a Provider submits claims for U0005, please note the following:

    1. Per the agreement with Avalon, Providers may be audited to confirm compliance with the turnaround time guidelines
    2. Providers found to have exceeded the two (2)-day turnaround time will be denied payment for further claims for U0005 until such time that the Provider can demonstrate their ability to meet the turnaround time requirement
    3. Reimbursement made for previous claims that exceeded the two (2)-day turnaround time will be offset against future reimbursement due to the Provider

    View Guidelines

    87426, 87631, 87632, 87633, 87635, 0098U, 0099U, 0100U, U0001, U0002, U0003, U0004

     

     

    U0003 and U0004 at $75 per test

    U0005: Laboratories that meet the turnaround times set forth in the CMS guidelines may file CPT code U0005 and be reimbursed the additional $25 per test. 

    South Dakota View Guidelines 86318, 86328, 86769, 87426, 87428, 87635, 87636, 87637, 87811, v0202U, 0223U, 0224U, 0240U, 0241U, C9803, G2023, G2024, U0001, U0002, U0003, U0004, CS Modifier
    Tennessee

    BCBS Tennessee has added U0005 to its list of acceptable codes for COVID-19 testing.

    View Guidelines

    87426, 87428, 87635, 87636, 87637, 87811, 0240U, 0241U, U0001, U0002, U0003, U0004, U0005
    Texas View Guidelines 86318, 86328, 86408, 86409, 86413, 86769, 87426, 87428, 87635, 87636, 87637, 87811, 0202U, 0223U, 0224U, 0225U, 0226U, 0240U, 0241U, C9803, G2023, G2024, U0001, U0002, U0003, U0004, CS Modifier 
    Utah

    Regence COVID-19 Testing Policy

    Regence COVID-19 Treatment Policy

    86328, 86413, 86769, 87426, 87428, 87499, 87635, 87636, 87637, 87811, 0202U, 0223U, 0224U,  0225U, 0240U, 0241U, C9803, G2023, G2024, U0001, U0002, U0003, U0004
    Vermont

    Commencing on January 25, 2021

    Laboratories may continue to bill for the COVID-19 codes U0003 and U0004 at their typical billed rate but should expect to be reimbursed at $75 per test.  It is the expectation of the health plans that Providers will only submit claims for U0005 if their current turnaround time is within the two (2)-day limit as described by CMS.  If a Provider submits claims for U0005, please note the following:

    1. Per the agreement with Avalon, Providers may be audited to confirm compliance with the turnaround time guidelines
    2. Providers found to have exceeded the two (2)-day turnaround time will be denied payment for further claims for U0005 until such time that the Provider can demonstrate their ability to meet the turnaround time requirement
    3. Reimbursement made for previous claims that exceeded the two (2)-day turnaround time will be offset against future reimbursement due to the Provider

    View  BSBS Vermont Guidelines

    86328, 86769, 87635, C9803, G2023 G2024, U0001, U0002, U0003, U0004, U0005

     

     

    U0003 and U0004 at $75 per test

    U0005: Laboratories that meet the turnaround times set forth in the CMS guidelines may file CPT code U0005 and be reimbursed the additional $25 per test. 

    Virginia View Anthem VA Guidelines  86328, 86769, 87635, U0001, U0002, U0003, U0004
    Virginia View Carefirst Guidelines 86328, 86769, 87426, 87635, 87636, 87637, 87811, 0225U, 0240U, 0241U , U0002, U0003, U0004 
    Washington View Premera Guidelines U0001, U0002, U0003, U0004, 86328 , 86769, 87635
    Washington

    Regence COVID-19 Testing Policy

    Regence COVID-19 Treatment Policy

    86328, 86413, 86769, 87426, 87428, 87499, 87635, 87636, 87637, 87811, 0202U, 0223U, 0224U,  0225U, 0240U, 0241U, C9803, G2023, G2024, U0001, U0002, U0003, U0004
    West Virginia View Guidelines 86328, 86769, 87635, C9803, G2023, G2024, U0001, U0002, U0003, U0004
    Wisconsin View Guidelines 86328, 86769, 87635, U0001, U0002, U0003, U0004
    Wyoming

     

    View Guidelines

    86328, 86408, 86409, 86769, 87426, 87635, 87636, 87637, 87811, 0202U, 0223U, 0224U, 0225U, 0226U, 0240U, 0241U, C9803, G2023, G2024, U0001, U0002, U0003, U0004

     

    January 7, 2021 | CMS Clarifies Documentation Requirements

    CMS updated the MLN Fact Sheet regarding the documentation requirements for laboratory services.  The document was revised to:

    • Clarify documentation requirements to add language acceptable to Medical Review Contractors auditing records for regulatory guidance compliance
      • Medical review contractors will consider diagnostic test order requirements met if there’s:
        • A signed order or requisition listing the specific test
        • An unsigned order or requisition listing the specific test(s) and an authenticated medical record supporting the physician’s intent to order the tests (for example, “order labs”, “check blood”, “repeat urine”)
        • An authenticated medical record supporting the physician intent to order specific tests
    • Add clarification to the term “standing orders”
      • Providers should be aware of the various meanings of the term “standing orders.” Some understand this to mean recurring orders specific to the care of an individual patient. Others interpret this as routine orders for services delivered to a population of patients. Only medically necessary services ordered and rendered, including those based on treatment protocols, are considered for reimbursement when documentation supports the orders and/or protocols are individualized to each patient.
    January 6, 2021 | Clarification on U0005 Definition of 'Majority'
    • COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing
      • https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf
        • Page 17
          • Question 11: CMS has indicated that in order to bill Medicare for HCPCS code U0005 the majority of a laboratory’s COVID-19 CDLTs performed using high throughput technology in the previous calendar month must have been completed in 2 calendar days or less from the date of specimen collection for all of their patients (not just their Medicare patients).  What does “majority” mean in this context?
          • Answer: For purposes of CMS Ruling No. CMS 2020-1-R2, https://www.cms.gov/files/document/cms-ruling-2020-1-r2.pdf, .  We note that the requirement that the majority of a laboratory’s COVID-19 CDLTs performed using high throughput technology in the previous calendar month must have been completed in 2 calendar days or less from the date of specimen collection pertains to the laboratory’s ability to bill Medicare for the $25 add-on payment using HCPCS code U0005.  Laboratories may continue to bill Medicare for COVID-19 CDLTs making use of high throughput technology described by HCPCS codes U0003 and U0004, regardless of whether they meet this requirement.
          • Effective date: CMS 2020-1-R2 is effective January 1, 2021.
    • Question 13: CMS Ruling No. CMS 2020-1-R2 states that for a laboratory to be able to bill Medicare for HCPCS code U0005, the test described by HCPCS code U0003 or U0004 must be completed in 2 calendar days. Please clarify when the 2-calendar day timeframe begins and ends.
    • Answer: Beginning with dates of service on or after January 1, 2021, laboratories can bill Medicare for the $25 add-on payment using HCPCS code U0005 when: 1) they completed the COVID-19 CDLT in 2 calendar days or less from the date of specimen collection; and 2) the majority of their COVID-19 CDLTs performed using high throughput technology in the previous calendar month were completed in 2 calendar days or less for all of their patients (not just their Medicare patients).  For example, if the specimen is collected anytime Wednesday then the COVID-19 CDLT would need to be completed, that is, results are finalized and ready for release, by 11:59PM Friday. In other words the specimen collection day (Wednesday) is day 0, Thursday is day 1.
    • Effective date: CMS 2020-1-R2 is effective January 1, 2021.
    UPDATED November 21, 2020 | Medicare Rates for COVID-19 Testing

    Medicare rates cover all 12 MAC jurisdictions

    U0001 U0002 U0003 U0004 U0005 86328 86769
    $35.91 $51.31 $100.00/$75.00(1) $100.00/$75.00(1) $25.00(2) $45.23 $42.13
    87426 87428 87635 87636 87637 87811 G2023 G2024
    $45.23 $73.49 $51.31 $142.63 $142.63 $42.13 $23.46 $25.46

    (1)  Effective January 1, 2021, reimbursement rate drops to $75 with possible addition of $25 for timely turnaround

    (2)  Effective January 1, 2021

    October 28, 2020 | CMS releases Interim Final Rule w/Comment Period for COVID-19 Price Transparency

    On October 28, 2020, the Centers for Medicare and Medicaid Services (CMS) released a pre-publication copy of an Interim Final Rule with Comment Period (IFC) that includes a section entitled “Price Transparency for COVID-19 Diagnostic Tests.” It implements the section of the CARES Act that requires each provider of a diagnostic test for COVID-19 to publicize cash prices for such testing
    on the provider’s website during the Public Health Emergency and imposes civil monetary penalties of $300/day for non-compliance. The IFC is effective immediately, Comments will be accepted through the date that is 60 days after publication in the Federal Register.

    Source: https://www.cms.gov/newsroom/fact-sheets/fourth-covid-19-interim-final-rule-comment-period-ifc-4

    Complete IFC document: https://www.cms.gov/files/document/covid-vax-ifc-4.pdf

    More about the Coverage Transparency Rule: https://www.cms.gov/newsroom/fact-sheets/transparency-coverage-final-rule-fact-sheet-cms-9915-f#_ftn1

    Questions about compliance can be directed to: COVID19CashPrice@cms.hhs.gov

    NEW October 19, 2020 | CMS Amends Administrative Ruling CMS-2020-1-R2 to Add Guidelines for U0005 Code

    CMS has released the Amended Administrative Ruling CMS-2020-1-R2, which provides coding guidelines for the new U0005 code and testing speed-driven reimbursement rates for high throughput COVID testing. 

    As required by the HCPCS code U0005 descriptor, the majority of a laboratory’s CDLTs making use of high throughput technologies for the detection of SARS-CoV2 or the diagnosis of the virus that causes COVID-19 for all patients (including non-Medicare patients) in the previous calendar month have to be completed in 2 calendar days or less from the date the specimen was collected. More specifically, laboratories would assess the timeliness of those tests in the month preceding the month identified by the line date of service for the corresponding CDLT (represented by HCPCS U0003 or U0004). In the circumstance that the laboratory has not completed 51% of its CDLTs making use of high throughput technologies for the detection of SARS-CoV-2 or the diagnosis of the virus that causes COVID-19 (for all patients) in 2 calendar days from the date the specimen was collected during the applicable month, it may not bill for HCPCS code U0005 with HCPCS codes U0003 or U0004. For example, a laboratory is submitting a claim to Medicare for a CDLT performed on high throughput technology for the detection of SARS-CoV-2 or the diagnosis of the virus that causes COVID-19 using HCPCS code U0003 with a line date of service of May 15, 2021. This laboratory would assess its performance based on CDLTs making use of high throughput technologies for the detection of SARS-CoV-2 or the diagnosis of the virus that causes COVID19 completed during the calendar month (April 1, 2021 – April 30, 2021) that precedes the month identified by the CDLT line date of service (May 2021). If the laboratory completed a total of 1000 of those CDLTs (including all such tests for non-Medicare patients) in April, and 490 of them had been completed within 2 calendar days of the specimen being collected, the laboratory would have a 49% test timeliness completion rate and may not bill for the $25 add-on payment as represented by HCPCS code U0005.

    Source: https://www.cms.gov/files/document/cms-ruling-2020-1-r2.pdf

    FAQ (high throughput specific FAQs begin on page 12): https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf

     

    October 15, 2020 |CMS Changes Medicare Payment to Support Faster COVID-19 Diagnostic Testing

    CMS is announcing that starting January 1, 2021, Medicare will pay $100 only to laboratories that complete high throughput COVID-19 diagnostic tests within two calendar days of the specimen being collected.  Also effective January 1, 2021, for laboratories that take longer than two days to complete these tests, Medicare will pay a rate of $75. CMS is working to ensure that patients who test positive for the virus are alerted quickly so they can self-isolate and receive medical treatment.

    Starting January 1, 2021, the amended Administrative Ruling (CMS 2020-1-R2) will lower the base payment amount for COVID-19 diagnostic tests run on high-throughput technology to $75 in accordance with CMS’s assessment of the resources needed to perform those tests. Also starting January 1, 2021, Medicare will make an additional $25 add-on payment to laboratories for a COVID-19 diagnostic test run on high throughput technology if the laboratory: a) completes the test in two calendar days or less, and b) completes the majority of their COVID-19 diagnostic tests that use high throughput technology in two calendar days or less for all of their patients (not just their Medicare patients) in the previous month. Laboratories that complete a majority of COVID-19 diagnostic tests run on high throughput technology within two days will be paid $100 per test by Medicare, while laboratories that take longer will receive $75 per test.  CMS established these requirements to support faster high throughput COVID-19 diagnostic testing and to ensure all patients (not just Medicare patients) benefit from faster testing. These actions will be implemented under the amended Administrative Ruling (CMS-2020-1-R2) and coding instructions for the $25 add-on payment (HCPCS code U0005) released today.

    Source: CMS Changes Medicare Payment to Support Faster COVID-19 Diagnostic Testing

    September 25, 2020 | LCD policies adding COVID-19 codes U0003 and U0004

    Two existing policies L37348/A56974 and L37713/A56851, have added the procedure codes U0003 and U0004 with diagnostic codes that limit the covered codes. Published in September, they are retroactively effective to 7/30/2020. 

    May 19, 2020 | CMS Publishes Medicare Administrative Contractor (MAC) COVID-19 Test Pricing

    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. The payment amounts are identified below. Source: https://www.cms.gov/files/document/mac-covid-19-test-pricing.pdf (published 5-19-20)

    Jurisdiction U0001 U0002 U0003 U0004 87635 86769 86328
    ALL 12 MAC Jurisdictions $35.91 $51.31 $100.00 $100.00 $51.31 $42.13 $45.23

     

    May 7, 2020 | CMS Relaxes Billing Requirements for Laboratory Tests Required for COVID-19 Diagnosis

    Any health care professional authorized under state law may order tests. Medicare will pay for tests without a written order from the treating physician or other practitioner:

    • If an order is not written, an ordering or referring National Provider Identifier (NPI) is not required on the claim
    • If an order is written, include the NPI of the ordering or referring professional, consistent with current billing guidelines

    List of Laboratory Tests andf Modified Requirements

    Interim Final Rule

    April 17, 2020 | ACLA obtains clarifications regarding use of new U-code for high throughput COVID-19 diagnostic testing

    4/17/20 ACLA obtains clarifications regarding use of new U-code for high throughput COVID-19 diagnostic testing. 

    • The effective date of the CMS Ruling and the codes is April 14, 2020.  It is not retroactive, so reimbursement for claims submitted to date using HCPCS code U0002 will remain $51.
    • A technology that can process more than 200 specimens a day using automatic processing qualifies as a “high-throughput technology,” even if it is used for LDTs and with a manufacturer’s kit, and even if the actual number of tests processed in a given day using the technology is below 200 total (because of low order volume or servicing of the platform).  The technologies included in the Ruling were examples, and there was not an intent to exclude a technology that otherwise would meet the definition.
    • The expectation is that in almost all cases, a lab using a high-throughput technology for COVID-19 testing would use U0003 (used to “identify tests that would otherwise be identified by CPT code 87635 but for being performed with high throughput technologies”).  CMS created U0004 (used to “identify tests that would otherwise be identified by U0002 but for being performed using high throughput technology”) just in case it is needed.
    • CMS does not know how the MACs will monitor the appropriate use of U0003 and U0004.  The expectation is that laboratories already maintain information that would allow them to “connect the dots at the back end” to support the use of U0003 or U0004, if they were subject to an audit.  As usual, it is each laboratory’s responsibility to ensure it codes appropriately.
    • CMS representatives said they do not know what would happen when the public health emergency is terminated and whether the codes (and the higher reimbursement) would “switch off.”
    • CMS is developing FAQs on these codes and will release them soon.
    April 15, 2020 | CMS announces increased reimbursement rates for COVID-19 related testing, introduces two new codes

    CMS announces new rate of $100 and provided the following guidance for the two newly introduced codes:

    CMS's PAYMENT FOR LABORATORY TESTS FOR THE DETECTION OF SARS–COV–2 OR THE DIAGNOSIS OF THE VIRUS THAT CAUSES COVID–19 MAKING USE OF HIGH THROUGHPUT TECHNOLOGIES

    CDLTs making use of high throughput technologies (as defined in this Ruling) and administered during the ongoing emergency period defined in paragraph (1)(B) of section 1135(g) of the Act beginning on or after March 18, 2020, for the detection of SARS–CoV–2 or the diagnosis of the virus that causes COVID–19, are new and involve high throughput machines (which are highly sophisticated equipment) which require more intensive technician training (to ensure the role of extremely skilled personnel) and more time intensive processes (to assure quality). A high throughput technology uses a platform that employs automated processing of more than two hundred specimens a day. Examples of high throughput technology as of April 14, 2020 include but are not limited to technologies marketed on that date as the Roche cobas 6800 System, Roche cobas 8800 System, Abbott m2000 System, Hologic Panther Fusion System, GeneXpert Infinity System, and NeuMoDx 288 Molecular. 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).

    These tests are a type of CDLT currently paid for under 3 CMS-Ruling 2020-1-R Medicare Part B. Specifically, the following codes would identify these tests:

    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.

    It is noted that U0003 should identify tests that would otherwise be identified by CPT code 87635 but for being performed with these high throughput technologies. It is further noted that U0004 should identify tests that would otherwise be identified by U0002 but for being performed with these high throughput technologies.

    Finally, it is noted that neither U0003 nor U0004 should be used for tests that detect COVID-19 antibodies. CMS intends to promptly evaluate payment for relevant CDLTs for COVID-19 testing that make use of high throughput technologies developed after this issuance upon request for payment at an appropriate rate.

    CONCLUSION With regard to CDLTs that make use of high throughput technologies (as defined in this Ruling), are administered during the ongoing emergency period defined in paragraph (1)(B) of section 1135(g) of the Act beginning on or after March 18, 2020, for the detection of SARS–CoV–2 or the diagnosis of the virus that causes COVID–19, and are a type of CDLT currently paid for under Medicare Part B using CPT code 87635 or U0002, such tests, as identified using U0003 or U0004 as appropriate, shall be paid for at the rate of $100. Payment for all other CDLTs remains at the current level. CMS intends to promptly evaluate payment for relevant CDLTs for COVID-19 testing that make use of high throughput technologies developed after this issuance upon request for payment at an appropriate rate.

    Source: https://www.cms.gov/files/document/cms-2020-01-r.pdf

    CMS press release: https://www.cms.gov/newsroom/press-releases/cms-increases-medicare-payment-high-production-coronavirus-lab-tests-0

    March 31, 2020 | To identify specimen collection for COVID-19 testing, CMS is establishing two new level II HCPCS codes

    Independent laboratories must use one of these HCPCS codes when billing Medicare for the nominal specimen collection fee for COVID-19 testing for the duration of the PHE for the COVID-19 pandemic. These new HCPCS codes are: 

    • 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

    CMS has stated, "we created the second Level II HCPCS code, G2024, because section 1834A(b)(5) of the Act and our regulations at § 414.507(f) require a higher fee for collecting a specimen from an individual in a SNF or by a laboratory on behalf of an HHA, as described previously in this section of the IFC. We will issue guidance when the PHE for the COVID-19 pandemic is over and when these codes are no longer valid and terminated in the HCPCS file and/or the CLFS as appropriate. In addition, Medicare payment for transportation and expenses for trained personnel to CMS-1744-IFC 99 collect specimens from homebound patients (as discussed in section II.F. of this IFC, relating to the clarification of homebound status under the Medicare home health benefit) and inpatients (not in a hospital) for purposes of COVID-19 testing will be made in accordance with existing instructions found in the Medicare Claims Processing Manual.

    "Independent laboratories must use the existing level II HCPCS codes when billing for the travel allowance, that is, the per mile travel allowance as described by HCPCS code P9603 and the flat rate travel allowance as described by HCPCS code P9604. Additionally, we are clarifying that paper documentation of miles traveled is not required and laboratories can maintain electronic logs with that information. However, laboratories will need to be able to produce these electronic logs in a form and manner that can be shared with MACs."

    Source: HHS federal register document, Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the
    COVID-19 Public Health Emergency
     see definitions of code use on pages 98-99.

    Source: cms.gov mln connects special edition 3/31/20

     

    Updated May 4, 2021

    States Website Accepted CPT/HCPCS Code(s)
    Alabama View Resource U0001, U0002
    Alaska View Resource U0001, U0002, U0005
    Arizona View Resource U0001, U0002, U0003, U0004, 86328, 86769, 87635, G2023, G2024, CR Modifier
    Arkansas View Resource U0001, U0002
    California

    NEW Jan 11, 2021: Update to Billing Policy for Infectious Agent Antigen Detection

    Effective for dates of service on or after January 1, 2021, CPT® code 87426 (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)]) may now be reported in conjunction with any of the following codes: 87635, U0002, U0003, U0004. An Erroneous Payment Correction (EPC) will be implemented to reprocess affected claims. The updated provider manual pages reflecting this change will be released in a future Medi-Cal Update.

    MediCal Rate Update 12-4-20. New COVID Testing Codes 87636, 87637 and 87811 Are Medi-Cal Benefits.

    Effective for dates of service on or after October 6, 2020, new CPT® codes 87636, 87637 and 87811 are Medi-Cal benefits. All three codes do not have any gender or age restrictions, have a frequency limit of one each per day, any provider, per patient, and may be billed with any valid ICD-10-CM codes.
    Two of the newly approved codes, 87636 (infectious agent detection by nucleic acid [DNA or RNA]; severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] [coronavirus disease (COVID-19)] and influenza virus types A and B, multiplex amplified probe technique) and 87637 (infectious agent detection by nucleic acid [DNA or RNA]; severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] [coronavirus disease (COVID-19)], influenza virus types A and B, and respiratory syncytial virus, multiplex amplified probe technique), allow a single test to simultaneously detect the novel coronavirus, and a combination of common viral infectious agents, including influenza A/B and respiratory syncytial virus.
    Also approved is a new category I CPT code 87811 (infectious agent antigen detection by immunoassay with direct optical [ie visual] observation; severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] [coronavirus disease (COVID-19)]).
    An Erroneous Payment Correction (EPC) will be implemented to reprocess affected claims. The updated manual pages reflecting this change will be released in a future Medi-Cal Update.

    MediCal Rate Update 10-5-20. Effective for dates of service on or after August 10, 2020, CPT® codes 86408 (neutralizing antibody, severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] [Coronavirus disease (COVID-19)]; screen) and 86409 (neutralizing antibody, severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] [Coronavirus disease (COVID-19)]; titer) have updated reimbursement rates.
    Additionally, the Department of Health Care Services (DHCS) is establishing the reimbursement rates at 100 percent of the Medicare rate for 86408 and 86409. These codes are 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, these rates 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.
    Updated rates are Code 86408: $42.13   Code 86409: $79.61

    View Resource 

    ——— 

    Medicaid California is accepting new code 87426, but has not yet published a rate. 

    ——— 

    As of 4/22 Medi-Cal is pricing U0003 and U0004 at 100% of Medicare rate without cuts or reductions View Resource 

    View News Release

    View Specimen collection info

     

    U0001, for providers using the CDC's 2019-nCoV Real-Time RT-PCR Diagnostic Panel test =  $35.91

    U0002, for providers performing COVID-19 testing by other techniques, not making use of high throughput technologies as described by CMS-2020-01-R = $51.31

    U0003, for providers performing COVID-19 testing by DNA or RNA amplified probe technique, making use of high throughput technologies as described by CMS-2020-01-R = $100

    U0004, for providers performing COVID-19 testing by other techniques, making use of high throughput technologies as described by CMS-2020-01-R = $100

    87635, for providers performing COVID-19 testing by DNA or RNA amplified probe technique, not making use of high throughput technologies as described by CMS-2020-01-R = $51.31

    G2023, G2024, QW Modifier

    Colorado

    Jan 2021: Colorado Medicaid will accept U0005. View January 2021 update.

    View COVID-19 Resource

    The following is a list of new procedure codes covered benefits under Health First Colorado effective for dates of service on or after January 1, 2021:

    Independent Laboratory U0005 80143 80151 80161 80167 80179 80181 80189 80193 80204 80210 81168 81191 81192 81193 81194 81278 81279 81338 81339 81351 81352 81353 81357 81360 81419 82077 82681

    Connecticut

    Jan 2021: Connecticut Medicaid will accept U0005

    Effective for dates of service January 1, 2021 and forward, the Department of Social Services (DSS) will update the reimbursement for clinical diagnostic laboratory tests (CDLTs) for the detection of SARS-CoV2 or for the diagnosis of the virus that causes COVID-19 when using high-throughput technologies consistent with the modified guidance published by the Centers for Medicare and Medicaid Services (CMS) in Ruling 2020-1- R2. The CMS ruling can be accessed here.

    Consistent with the guidance issued in the CMS Ruling 2020-1-R2, effective January 1, 2021, DSS will implement the following reimbursement updates for CDLTs that utilize high-throughput technology:

    • Reimbursement for high throughput tests billed with procedure codes U0003 and U0004 will be priced at $75.00; and

    • Add-on procedure code U0005 will be added to the laboratory fee schedule and priced at $25.00. The add-on code U0005 was created to be billed in combination with procedure codes U0003 or U0004 only when providers meet the specific criteria outlined by CMS. See the section titled Add-on Code U0005 Criteria and the CMS Ruling 2020-1-R2 for more information on when to bill with add-on code U0005

    View Resource

    U0001, U0002, U0005

    Reimbursement for high throughput tests billed with procedure codes U0003 and U0004 will be priced at $75.00; and

    • Add-on procedure code U0005 will be added to the laboratory fee schedule and priced at $25.00. The add-on code U0005 was created to be billed in combination with procedure codes U0003 or U0004 only when providers meet the specific criteria outlined by CMS. See the section titled Add-on Code U0005 Criteria and the CMS Ruling 2020-1-R2 for more information on when to bill with add-on code U0005

    Delaware View Resource U0001, U0002
    Florida View Resource

    U0001, U0002, U0003, U0004, 86328, 86769, 87635

    Georgia View Resource U0001, U0002, 87635
    Hawaii View Resource U0001, U0002, 87635
    Idaho View Resource U0001, U0002, 87635, U0005
    Illinois View Resource, Update U0001, U0002, U0003, U0004, 87635, U0005
    Indiana

    View Resource

    3/22/21: Rate decrease for HCPCS codes U0003 and U0004
    As a result of changes to the Medicare reimbursement rates, IHCP Medicaid reimbursement of the following Healthcare Common Procedure Coding System (HCPCS) codes associated with coronavirus disease 2019 (COVID-19) testing will decrease from a maximum fee of $100.00 to $75.00, effective retroactively for professional and outpatient claims with DOS on or after January 1, 2021.

    Claims for codes U0003 and U0004 that paid incorrectly The IHCP identified a claim-processing issue that affects FFS professional and outpatient claims for procedure codes U0003 and U0004, with DOS on or after January 1, 2021. Claims or claim details may have paid incorrectly. The claim-processing system has been updated with the new rate. Claims processed during the indicated time frame for codes U0003 and U0004 will be mass adjusted, as appropriate. Providers should see adjusted claims on Remittance Advices (RAs) beginning April 21, 2021, with internal control numbers (ICNs)/Claim IDs that begin with 52 (mass replacements non-check related).

    If a claim was overpaid, the net difference will appear as an account's receivable on the RA. The accounts receivable will be recouped at 100% from future claims paid to the respective provider number.

    Add-on payment using HCPCS code U0005 Effective January 1, 2021, the Centers for Medicare & Medicaid Services (CMS) released HCPCS code U0005 – 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, CDC or non-CDC, making use of high throughput technologies, completed within two calendar days from date and time of specimen collection.

    Claims for add-on payment If a provider met the criteria (above) for billing code U0005 with a claim for procedure code U0003 or U0004 with DOS on or after January 1, 2021, the provider may choose to adjust the original claim by voiding the original and submitting a replacement. CMS guidance states that U0005 must be billed on the same claim as U0003 or U0004. The replacement claim must include the same attachments (if any) as were submitted with the original claim. Providers have 180 days from the date of this banner page publication to adjust claims. Replacement claims submitted beyond the original 180 day filing limit must include a copy of this banner page as an attachment and must be filed within 180 days of the publication date.

    U0001, U0002, 87635, U0005
    Iowa

    Billing Related to Covid-19

    Provider Toolkit

    U0001, U0002, 87635, U0005
    Kansas View Resource U0001, U0002, 87635, U0005
    Kentucky View Resource U0001, U0002, U0003, U0004, 87635, U0005
    Louisiana View Resource U0002
    Maine View Resource U0001, U0002, 87635, U0005
    Maryland View Resource U0002, 87635
    Massachusetts View Resource U0002, 87635
    Michigan View Resource U0001, U0002, 87635, U0005
    Minnesota View Resource U0001, U0002, 87635, U0005
    Mississippi View Resource U0001, U0002, U0003, U0004, 87635, G2023, G2024
    Missouri View Resource U0001, U0002, U0003, U0004, 87635, G2023, G2024, U0005
    Montana View Resource U0001, U0002, 87635, U0005
    Nebraska View Resource U0001, U0002, U0005
    Nevada View Resource U0001, U0002, 87635, U0005
    New Hampshire View Resource U0001, U0002, 87635
    New Jersey View Resource U0002, U0005
    New Mexico

    Jan 25, 2021: U0005 Guidance:

    Modification of payment for clinical diagnostic laboratory tests (CDLTs) for the detection of SARS–CoV–2 or the diagnosis of the virus that causes COVID-19 making use of high throughput technologies for HCPCS code U0003, U0004, and U0005 effective January 2, 2021.

     

    CMS has established a payment amount of $75 per test for CDLTs making use of high throughput technologies for the detection of SARS-CoV-2 or the diagnosis of the virus that causes COVID-19, as identified by HCPCS codes U0003 and U0004.  CMS has established a new add-on payment of $25 as identified by HCPCS code U0005. As required by the HCPCS code U0005 descriptor, this add-on payment may be billed with either HCPCS code U0003 or HCPCS code U0004 when the applicable test is completed within 2 calendar days of the specimen being collected.

     

    Laboratories that do not complete the CDLT making use of high throughput technologies for the detection of SARS-CoV-2 or the diagnosis of the virus that causes COVID-19 within 2 calendar days may not bill HCPCS code U0005 and will not receive the $25 add-on payment. Payment for these CDLTs will be $75.  Under the Medicare guidance, the responsibility is with providers to determine their eligibility to bill for this additional payment and is subject to audit or medical review (see page 7 of the CMS policy https://www.cms.gov/files/document/cms-ruling-2020-1-r2.pdf).

     

    In the event of an audit or medical review, laboratories will need to produce documentation to support the add-on payment established in this Ruling, even if such documentation would not otherwise be required under Medicare regulations.

    For additional guidance please visit https://www.cms.gov/files/document/cms-ruling-2020-1-r2.pdf.

    View Resource

    U0001, U0002, 87635, U0005

    U0005: $75/$75+$25

    New York View Resource U0001, U0002, U0005
    North Carolina View Resource U0001, U0002, U0005, 87635
    North Dakota View Resource U0001, U0002, U0003, U0004, 87635
    Ohio View Resource U0001, U0002, 87635, U0005
    Oklahoma View Resource U0001, U0002, U0003, U0004, U0005
    Oregon View Resource H0001, U0002, 86328, 86769, 87635, U0005
    Pennsylvania

    View Resource

    U0001, U0002, U0003, U0004, 86328, 86769, 87635, QW Modifier

    Pricing for antibody tests: 

    86328 $5.58

    86769 $11.16

    Rhode Island View Resource U0001, U0002, 87635
    South Carolina View Resource U0001, U0002
    South Dakota View Resource U0001, U0002, U0003, U0004
    Tennessee View Resource U0001, U0002, 87635
    Texas View Resource U0001, U0002, U0005
    Utah View Resource U0001, U0002, 86318, 86328, 86769, 87635
    Vermont View Resource U0001, U0002, 87635, U0005
    Virginia View Resource U0001, U0002, U0005
    Washington View Resource U0001, U0002, U0005
    West Virginia

    Vew Instructions

    View Update

    U0001, U0002, 87635, G2023, G2024, U0005
    Wisconsin View Resource U0001, U0002, 87635
    Wyoming View Resource U0001, U0002, U0003, U0004, 87635, G2023, G2024, U0005

     

    1-26-21: HRSA payments are being held until February 4, 2021 to update the new CMS rates on COVID-19

    1-13-21: U0005 for HRSA COVID-19 Uninsured Program: Beginning, January 1, 2021, Medicare will reimburse independent laboratories $75 per claim (HCPCS codes U0003 and U0004) with a potential add-on reimbursement of $25 (HCPCS code U0005) if the laboratory returned results to patients within 48 hours and returned results for a majority of its tests (Medicare and non-Medicare) during the previous calendar month within two days. The HRSA COVID-19 Uninsured Program plans to continue to reimburse independent laboratories at a rate of $100 for COVID-19 PCR testing claims with HCPCS codes U0003 and U0004 and will not implement the add-on reimbursement for HCPCS U0005 in January 2021. https://www.hrsa.gov/coviduninsuredclaim/frequently-asked-questions

    11-16-20: Will HRSA cover COVID-19 testing if a patient's commercial insurance denies the claim? HRSA/United Health Group will only reimburse claims for uninsured patients.  By submitting the Patient Roster, the provider attests to the patient not having healthcare coverage (to the best of their knowledge).  The information goes through eligibility; therefore, if the eligibility transaction returns insurance, a temporary subscriber ID number will not be provided for claims submission.

    COVID-19 Billing Background

    Due to the emergent nature of the public health concern surrounding the novel coronavirus testing, both the Centers for Medicare and Medicaid Services (CMS) and the American Medical Association (AMA) developed specific billing codes to help increase testing and track new cases.

     On February 13, 2020, CMS developed a new Healthcare Common Procedure Coding System (HCPCS) code for providers and laboratories to test patients for SARS-CoV-2.  HCPCS code U0001 is used for CDC testing laboratories.  On February 29, 2020, the Food and Drug Administration (FDA) issued a new policy for certain laboratories to develop their own validated COVID-19 diagnostic test.  HCPCS code U0002 was announced on March 5, 2020, which allows these laboratories to bill for non-CDC laboratory tests for SARS-CoV-2/2019-nCoV (COVID-19).   

     On March 13, 2020, the American Medical Association (AMA) Current Procedural Terminology (CPT) Editorial Panel convened in a special meeting and approved a new code to describe the laboratory test for severe acute respiratory syndrome corona-virus 2 (SARS-CoV-2).  Although, not included in the 2020 CPT publication, CPT code 87635 (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; is effective immediately for use to report this test service.  It will be included in the 2021 code set in the Microbiology subsection under the Pathology and Laboratory section of the CPT manual.

    NEW: COVID Vaccination Program Information--Registration and Billing

    The CDC COVID-19 Vaccination Program Provider Requirements and Support can be found here: https://www.cdc.gov/vaccines/covid-19/vaccination-provider-support.html

    NEW 8-26-21: AMA's published vaccine-specific CPT codes

    Recently, the American Medical Association (AMA) announced that the Current Procedural Terminology (CPT®) code set would be ready for the rollout of third doses of the Pfizer COVID-19 vaccine. This brings the number of COVID-19 vaccination CPT codes to 11, including third dose codes for both Moderna and Pfizer. You can access an up to date listing of AMA's COVID vaccine CPT codes here: https://www.ama-assn.org/system/files/2021-01/covid-19-immunizations-appendix-q-table.pdf

    Short, medium and long descriptors for all the new vaccine-specific CPT codes can be accessed on the AMA website, along with several other recent modifications to the CPT code set that have helped streamline the public health response to the SARS-CoV-2 virus and the COVID-19 disease.

    1-18-21 Notes on Vaccine Administration and Billing for Medicare

    NOTE: Medicare is expediting the temporary billing privileges for providers (please see information below, which requires a phone call to the MAC with basic information, and notification of status within 24 hours).  The provider will also need to sign an agreement with the US Government (https://www.cms.gov/files/document/COVID-19-toolkit-issuers-MA-plans.pdf).

    Medicare Enrollment for Administering COVID-19 Vaccine

    Institutional Non-Institutional
    • Hospital
    • Hospital Outpatient Department
    • Skilled Nursing Facility (includes Parts A and B)
    • Critical Access Hospital
    • End-Stage Renal Disease Facility
    • Home Health Agency
    • Hospice
    • Comprehensive Outpatient Rehabilitation Facility
    • Federally Qualified Health Center
    • Rural Health Clinic
    • Indian Health Services Facility
    • Physician
    • Non-Physician
    • Clinic/Group Practice
    • Pharmacy (enrolled as Part B)
    • Mass Immunizer (roster bill only)
    Institutional Non-Institutional Durable Medical Equipment (DME)
    • Outpatient Physical Therapy
    • Occupational Therapy
    • Speech Pathology Services
    • Histocompatibility Laboratory
    • Religious Non-Medical Health Care Institution
    • Independent Clinical Laboratory
    • Ambulance Service Supplier
    • Independent Diagnostic Testing Facility
    • Intensive Cardiac Rehabilitation Supplier
    • Mammography Center
    • Medicare Diabetes Prevention Program Suppliers
    • Portable X-ray Supplier
    • Radiation Therapy Center
    • Opioid Treatment Program
    • Organ Procurement Organization
    • Home Infusion Therapy Supplier
    • Durable Medical Equipment Supplier
    • Pharmacy (enrolled as DME supplier)
    • If you are not enrolled as a Medicare provider, you must qualify and enroll as a mass immunizer or other Medicare provider type that allows billing for administering vaccines. (https://www.cms.gov/files/document/covid-19-vaccine-enrollment-scenario-3.pdf)
      • Contact your MAC specific COVID-19 Hotline with the following information (https://www.cms.gov/files/document/covid-19-mac-hotlines.pdf)
        • Legal Business Name (LBN).
        • National Provider Identifier (NPI).
        • Tax Identification Number (TIN).
        • Practice Location and State License, if applicable
      • Notification of temporary Medicare billing privileges are provided within 24 hours.
    • Centralized Billing Enrollment
      • Centralized billing allows mass immunizers to send all roster bill claims for flu, pneumococcal, and soon COVID-19 vaccinations to a single Medicare Administrative Contractor (MAC), Novitas, for payment, regardless of where you administer the shot.
        • To become a centralized biller, call Novitas at 1-855-247-8428 with this information:
          • Estimate of how many patients to whom you expect to administer the COVID-19 vaccine.
          • Approximate dates of shots.
          • List of states for COVID-19 vaccination clinics.
          • Type of services you generally deliver other than preventive vaccinations, if any (for example, ambulance, home health, visiting nurse).
          • If you employ nurses who will administer the COVID-19 shot or if you hired them specifically to give these shots.
          • Names and addresses of all entities operating under provider application.
          • Contact information for the centralized billing program designated contact.

    Medicare Billing for COVID-19 Vaccine Administration

    • COVID-19 vaccine can be billed as a single claim or roster bill for multiple patients.
    • If government is providing the vaccine doses, only bill the administration code (0001A, 0002A, 0011A, 0012A).
    • Medicare Advantage Plan claims should be billed to the Medicare MAC.
    • Professional Claims
    • Institutional Claims
      • Roster billing can be used if administering vaccine to at least 5 patients on same date of service unless institution is an inpatient hospital.
        • For hospitalized patients, Medicare pays for the COVID-19 shots separately from the Diagnosis-Related Group rate and disallows billing them on 11X.
      • Valid types of bills for roster billing:
        • 12X, Hospital Inpatient**
        • 13X, Hospital Outpatient**
        • 22X, Skilled Nursing Facility (SNF) covered Part A stay (paid under Part B) & Inpatient Part B
        • 23X, SNF Outpatient
        • 34X, Home Health (Part B Only)
        • 72X, Independent and Hospital-based Renal Dialysis Facility
        • 75X, Comprehensive Outpatient Rehabilitation Facility
        • 81X, Hospice (Non-hospital)
        • 82X, Hospice (Hospital)
        • 85X, Critical Access Hospital
    • COVID-19 Vaccine Coding
    • The government is currently providing the vaccine product; therefore, CPT code 91300 and 91301 should not be billed.
    Code CPT Short Descriptor Labeler Name Vaccine/Procedure Name Payment Allowance Effective Dates
    91300

    SARSCOV2 VAC 

    30MCG/0.3ML IM

    Pfizer Pfizer-Biontech Covid-19 Vaccine $0.010 12/11/2020 - TBD
    0001A

    ADM SARSCOV2

    30MCG/0.3ML 1ST

    Pfizer Pfizer-Biontech Covid-19 Vaccine--first dose $16.940 12/11/2020 - TBD
    0002A

    ADM SARSCOV2

    30MCG/0.3ML 2ND

    Pfizer Pfizer-Biontech Covid-19 Vaccine--second dose $28.390 12/11/2020 - TBD
    91301

    SARSCOV2 VAC 

    100MCG/0.5ML IM

    Moderna Moderna Covid-19 Vaccine $0.010 12/11/2020 - TBD
    0011A

    ADM SARSCOV2

    100MCG/0.5ML 1ST

    Moderna Moderna Covid-19 Vaccine Administration --first dose $16.940 12/18/2020 - TBD
    0012A

    ADM SARSCOV2

    100MCG/0.5ML 2ND

    Moderna oderna Covid-19 Vaccine Administration --second dose $28.390 12/18/2020 - TBD
    91302

    SARSCOV2 VAC 

    5X10^10VP/0.5ML IM

    AstraZeneca AstraZeneca Covid-19 Vaccine $0.010 12/18/2020 - TBD
    0021A

    ADM SARSCOV2

    5X10^10VP/0.5ML 1

    AstraZeneca AstraZeneca Covid-19 Vaccine--first dose $16.940  
    0022A

    ADM SARSCOV2

    5X10^10VP/0.5ML 2

    AstraZeneca AstraZeneca Covid-19 Vaccine--second dose $28.390  
    • HRSA COVID-19 Uninsured Program
      • Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136), which provides $100 billion in relief funds, including to hospitals and other health care providers on the front lines of the COVID-19 response, and the PPPHCEA, which appropriated an additional $75 billion in relief funds. Within the Provider Relief Fund, a portion of the funding will be used to support healthcare-related expenses attributable to the treatment of uninsured individuals with COVID-19. A portion of the funding will also be used for COVID-19 vaccine administration to uninsured individuals when the Food and Drug Administration (FDA) authorizes a vaccine under an Emergency Use Authorization (EUA) or licenses a vaccine under a Biologics License Application (BLA) (https://www.hrsa.gov/CovidUninsuredClaim).
    • State Medicaid Enrollment
    State Health Department websites
    State Health Department Website for COVID-19 Vaccination Program and Provider Enrollment
    Alabama https://www.alabamapublichealth.gov/immunization/covid-vaccine-administration.html#enroll
    Alaska http://dhss.alaska.gov/dph/Epi/id/Pages/COVID-19/vaccineproviders.aspx#enrollment
    Arizona https://redcapaipo.azdhs.gov/surveys/?s=DY8CA9LMJ8
    Arkansas https://redcapdhs.adh.arkansas.gov/redcap/surveys/index.php?s=ALRWJPE7YT
    California https://eziz.org/covid/enrollment/
    Colorado https://drive.google.com/file/d/1O713W0DasDGiLhGPbowsGI1KaKSeAVuW/view 
    Connecticut https://portal.ct.gov/DPH/Immunizations/COVID-19-Vaccine-Providers
    Delaware https://coronavirus.delaware.gov/wp-content/uploads/sites/177/2021/01/20210106-DE-Vx-Enrollment-Instructions-vF.pdf
    District of Columbia https://coronavirus.dc.gov/sites/default/files/dc/sites/coronavirus/page_content/attachments/COVID-19%20Vaccine%20Provider%20Agreement%20FAQ_v2%20%281%29.pdf
    Florida http://www.floridahealth.gov/programs-and-services/immunization/COVID-19VaccineInfo/index.html#:~:text=Note%3A%20To%20become%20a%20COVID,Vaccines%20for%20Children%2FAdult%20Program.&text=For%20questions%20or%20additional%20information,email%20CovidVaccineProgram%40flhealth.gov.
    Georgia https://dph.georgia.gov/provider-vaccine-registration-ph-district-list
    Hawaii https://health.hawaii.gov/coronavirusdisease2019/for-clinicians/covid-19-vaccine/
    Idaho https://healthandwelfare.idaho.gov/providers/immunization-providers/covid-19-vaccination-providers
    Illinois https://www.dph.illinois.gov/covid19/vaccination-plan
    Indiana https://www.coronavirus.in.gov/files/COVID-19%20provider%20enrollment%20FAQ%2010.21.20.pdf
    Iowa https://idph.iowa.gov/Portals/1/userfiles/61/covid19/vaccine/COVID-19%20Vaccine%20Provider%20Enrollment%20Letter%209_29_20%20%281%29.pdf
    Kansas https://kanphix.kdhe.state.ks.us/KDHECDCCovidVaccineEnroll/
    Kentucky https://govstatus.egov.com/ky-healthcare-guidance
    Louisiana https://ldh.la.gov/index.cfm/page/4073
    Maine https://www.maine.gov/dhhs/mecdc/infectious-disease/immunization/covid-19-providers/enrollment.shtml
    Maryland https://health.maryland.gov/mdpcp/Documents/Covid%20flash%2012-14-20_Final.pdf
    Massachusetts https://www.mass.gov/info-details/massachusetts-covid-19-vaccine-program-mcvp-guidance-for-vaccine-providers-and#guide-to-applying-to-administer-the-covid-19-vaccine-
    Michigan https://www.michigan.gov/mdhhs/0,5885,7-339-73971_4911_4914-545768--,00.html
    Minnesota https://www.health.state.mn.us/diseases/coronavirus/vaccine/vaxreg.html
    Mississippi https://msdh.ms.gov/msdhsite/index.cfm/14,22548,71,975,html
    Missouri https://health.mo.gov/living/healthcondiseases/communicable/novel-coronavirus/vaccine-enrollment.php
    Montana https://mtha.org/wp-content/uploads/2020/10/Montana-COVID-19-Vaccine-Provider-Enrollment.pdf
    Nebraska http://dhhs.ne.gov/Pages/COVID-19-Vaccine-Information-For-Health-Care-Providers.aspx
    Nevada http://dpbh.nv.gov/Programs/Immunization/COVID/COVID_Vaccine/
    New Hampshire https://www.nh.gov/covid19/resources-guidance/vaccination-planning.htm
    New Jersey https://njiis.nj.gov/core/web/index.html#/newFacilityEnrollment
    New Mexico https://cv.nmhealth.org/providers/vaccines/
    New York https://coronavirus.health.ny.gov/covid-19-vaccine-information-providers
    https://www1.nyc.gov/site/doh/providers/reporting-and-services/citywide-immunization-registry-cir.page
    North Carolina https://immunize.nc.gov/providers/covid-19training.htm
    North Dakota https://www.health.nd.gov/immunization-guidance-health-care-providers
    Ohio https://odh.ohio.gov/wps/portal/gov/odh/know-our-programs/covid-19-vaccine-provider/ohio-covid-19-provider-enrollment/ohio-covid-19-provider-enrollment
    Oklahoma https://oklahoma.gov/covid19/vaccine-information/provider-enrollment-process.html
    Oregon https://www.oregon.gov/oha/PH/PREVENTIONWELLNESS/VACCINESIMMUNIZATION/IMMUNIZATIONPROVIDERRESOURCES/Pages/COVIDvaccine.aspx
    Pennsylvania https://www.health.pa.gov/topics/disease/coronavirus/Pages/Guidance/HCP-To-Enroll-To-Provide-COVID-19-Vaccine.aspx
    Rhode Island https://covid.ri.gov/healthcare-professionals/vaccine-information-healthcare-providers
    South Carolina https://scdhec.gov/covid19/guidance-healthcare-professionals-covid-19/covid-19-vaccine-provider-enrollment
    South Dakota https://doh.sd.gov/COVID/Vaccine/Providers.aspx
    Tennessee https://www.tn.gov/health/cedep/ncov/covid-19-vaccine-information-for-healthcare-providers.html
    Texas https://dshs.texas.gov/coronavirus/immunize/provider-enrollment.aspx
    Utah https://immunize.utah.gov/covid-19-vaccine/
    Vermont https://www.healthvermont.gov/sites/default/files/documents/pdf/COVID19-VaccineEnrollmentProcess.pdf
    Virginia https://www.vdh.virginia.gov/content/uploads/sites/11/2020/10/COVID-19-Vaccine-Provider-Intent-Form-Instructions.pdf
    Washington https://www.doh.wa.gov/Portals/1/Documents/1600/coronavirus/COVID-19-Provider-Enrollment-Guide.pdf
    West Virginia https://dhhr.wv.gov/COVID-19/Pages/Provider-Resources.aspx
    Wisconsin https://www.dhs.wisconsin.gov/covid-19/vaccine-program.htm
    Wyoming https://health.wyo.gov/publichealth/immunization/wyoming-covid-19-vaccine-information/covidvaccineproviders/#:~:text=COVID%2D19%20Vaccination%20Program%20Templates%20and%20Forms&text=COVID%2D19%20Shot%20Card%20%E2%80%93%20enrolled,COVID%2D19%20Vaccine%20Shot%20Cards.

    CARES Act Loan Programs, Laboratory Impact

    On Friday March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act was signed into law. It has many sections, but a few in particular affect diagnostic providers. Click the expander button to see information about Medicare’s accelerated/advanced payments, provider eligibility and process, and also access fact sheets and other resources:

    November 18, 2020: Provider Requirement to post Cash Price of COVID-19 Diagnostic Testing pursuant to CARES Act

    Provision 3202(a) & 3202(b) of the CARES Act requires all providers of diagnostic testing for COVID-19 to publicly post the cash price for such a test on the provider’s website (there are options for public posting if the provider has no website). CMS may impose civil monetary penalties of up to $300/day for violations of this requirement. 

    HHS has issued additional regulations to clarify the scope of this provision of the CARES Act. Specifically, HHS has indicated that “each provider of a COVID-19 diagnostic test that has a website make public the cash price information…and that the information itself, or a link to a web page that contains such information, must appear in a conspicuous location on a searchable homepage on the provider’s website”. HHS notes that the following terms should be included on the provider’s homepage in connection with this requirement: The provider’s name; “price”; “cost”; “test”; COVID”; and “coronavirus”. If the provider has no website, then the provider will be required to make public its cash price information in writing upon request within two business days to the requestor (an email will suffice here) and by posting signage prominently at the location where the provider offers a COVID-19 diagnostic testing in a place likely to be viewed by members of the public seeking to obtain and pay for such testing. Note, HHS has sought public comment on the additional regulations promulgated on November 2, 2020. The deadline for comment is January 4, 2021, however, the regulations are effective from November 2, 2020 through the end of the Public Health Emergency.

    If CMS determines a provider is noncompliant with the requirement to post the cash price of COVID-19 diagnostic testing, it may issue a warning notice and may require that the provider prepare a Corrective Action Plan (CAP), which would include the corrective actions or processes the provider will take to address the deficiency identified by CMS, and the timeframe by which the provider will complete the corrective action. The CAP would then be subject to CMS’ review and approval. If the provider fails to respond to CMS’ request to submit a CAP or comply with a CAP approved by CMS, civil monetary penalties of up to $300/day may be imposed.

    https://www.jdsupra.com/legalnews/provider-requirement-to-post-cash-price-23102/?origin

    October 8, 2020: CMS Announces New Repayment Terms for Medicare Loans Made to Providers During COVID-19

    New recoupment terms allow providers and suppliers one additional year to start loan payments.

    CMS announced amended terms for payments issued under the Accelerated and Advance Payment (AAP) Program. Under the Continuing Appropriations Act, 2021 and Other Extensions Act, repayment will now begin one year from the issuance date of each provider or supplier’s accelerated or advance payment. In addition, the interest rate applied to outstanding balances after 29 months has also been lowered to 4% instead of 10.25%.

    For more information:

    Webinar: Received COVID-19 Funding? How to Mitigate & Respond to Enforcement Risks and Government Actions

    On Wednesday, July 15, law firm Mintz is hosting a webinar about enforcement risks stemming from COVID-19 relief and stimulus funds. The global pandemic has caused many businesses to apply for grants and/or loans or accept and retain federal funds under the CARES Act and other federally funded relief programs. Mintz’s COVID-19 Compliance & Enforcement Defense Task Force will review how to avoid risk and how to address enforcement when it arises. Learn more and register

    CARES Act Requires Providers of COVID-19 Testing to Post Test Rates

    One CARES act provision of note is the requirement for providers of COVID-19 diagnostic testing to publish the cash price for the test on their website. The requirement appears to last for the duration of the emergency declaration. The requirement also applies to any “provider of diagnostic testing” for the COVID-19 virus and is not limited to clinical laboratories. Test providers who do not publish the cash price for their testing can be subject to imposition of civil monetary penalties of up to $300 per day. 

    CARES Act Section 4202

    Coronavirus Aid, Relief, and Economic Security (CARES) Act Establishes New Loan Opportunities

    Paycheck Protection Program

    Businesses with less than 500 employees (full and part time, including broadly defined affiliates), and certain companies with more than 500 employees, are eligible for up to $10 million in loans to cover expenses.  Loan amount is up to 2.5 times the last year’s average monthly payroll costs (with some limitations), with a two year term, 1% annual interest, and six month interest deferral.  No collateral or personal guarantees are required.  Loan forgiveness is equal to the expenditures during the first eight weeks of the loan, reduced by certain reductions in employee pay or workforce.  Only available through June 30, 2020.    

    Emergency Injury Disaster Loan Program (EIDL) Grants

    Businesses with less than 500 employees (full and part time, including broadly defined affiliates) are eligible for up to $2 million in loans with below market interest rates and up to 30 year terms, with a $10,000 loan advance within 3 days of application. 

    Mid-Market Loan Program

    The CARES Act authorizes the U.S. Treasury Department to make mid-market loans at no more than 2% interest and a term not longer than 5 years, with limitations on staffing changes, stock buybacks and dividends, and imposes other limitations.  The program has not yet been established, and businesses should monitor the Treasury Department’s website.

    CMS has expanded the Accelerated and Advance Payments Program for Providers and Suppliers during the COVID-19 emergency: 

    • A broader group of qualified Part A providers and Part B suppliers are eligible for accelerated or advanced payments
    • Most eligible providers and suppliers can request up to 100% of Medicare payments for a three month period
    • Requests will be processed quickly, with a seven day turnaround goal
    • Repayment over 210 days

    https://www.cms.gov/files/document/Accelerated-and-Advanced-Payments-Fact-Sheet.pdf

    Additional CARES Act funding can be expected; health care businesses should monitor the HHS and Treasury Department websites for further announcements and prepare by documenting losses arising from COVID-19 circumstances. 

    The CARES Act also provides a number of tax benefits for eligible employers:

    Retention credit for employees retained but not working because of the coronavirus Section 2301
    Deferment of certain social security payments due on wages through 2020 Section 2302
    Modification to net operating losses for prior years Section 2303
    AMT revisions Section 2305
    Increased deductions for certain business interest charges Section 2306
    Bonus depreciation for certain real estate improvements Section 2307
    Advance refunding of certain credits for paid sick time and leave Section 3605
    Provider Emergency Relief Fund

    NEW 10-6-20: Phase 3 Provider Relief Funding — $20 billion in new funding for providers on the front lines of the coronavirus pandemic.

    Under this Phase 3 General Distribution allocation, providers that have already received Provider Relief Fund payments will be invited to apply for additional funding that considers financial losses and changes in operating expenses caused by the coronavirus. Previously ineligible providers, such as those who began practicing in 2020 will also be invited to apply, and an expanded group of behavioral health providers confronting the emergence of increased mental health and substance use issues exacerbated by the pandemic will also be eligible for relief payments.

    Providers can begin applying for funds on Monday, October 5, 2020.

    Payment Methodology – Apply Early

    All eligible providers will be considered for payment against the below criteria.

    1. All provider submissions will be reviewed to confirm they have received a Provider Relief Fund payment equal to approximately 2 percent of patient care revenue from prior general distributions. Applicants that have not yet received Relief Fund payments of 2 percent of patient revenue will receive a payment that, when combined with prior payments (if any), equals 2 percent of patient care revenue.
    2. With the remaining balance of the $20 billion budget, HRSA will then calculate an equitable add-on payment that considers the following:
      • A provider’s change in operating revenues from patient care
      • A provider’s change in operating expenses from patient care, including expenses incurred related to coronavirus
      • Payments already received through prior Provider Relief Fund distributions.

    We know providers want to receive payments shortly after submitting their information. However, this distribution requires cooperation on the part of all applicants. Again, HHS is urging all eligible providers to apply early; do not wait until the last day or week of the application period. Applying early will help to expedite HHS’s review process and payment calculations, and ultimately accelerate the distribution of all payments.

    All payment recipients will be required to attest to receiving the Phase 3 General Distribution payment and accept the associated Terms and Conditions.

    Application Deadline

    Providers will have from October 5, 2020 through November 6, 2020 to apply for Phase 3 General Distribution funding. HHS’s top priority is ensuring as many providers possible have an opportunity to apply. HHS will continue to host webinars to assist providers through the application process and the call center is also available to address questions.

    HHS recognizes the multifaceted challenges of this pandemic cannot be won without frontline healthcare providers focused on containing the virus and delivering holistic care. Funding for this Phase 3 General Distribution was made possible through the bipartisan CARES Act and the Paycheck Protection Program and Health Care Enhancement Act, which allocated $175 billion in relief funds to hospitals and other healthcare providers.

    For updates and to learn more, visit:https://www.hhs.gov/coronavirus/cares-act-provider-relief-fund/for-providers/index.html.

    Provider Emergency Relief Fund: Immediate infusion of $30 billion into healthcare system https://www.hhs.gov/provider-relief/index.html

    Recognizing the importance of delivering funds in a fast and transparent manner, $30 billion is being distributed immediately – with payments arriving via direct deposit beginning April 10, 2020 – to eligible providers throughout the American healthcare system. These are payments, not loans, to healthcare providers, and will not need to be repaid.

    All facilities and providers that received Medicare fee-for-service (FFS) reimbursements in 2019 are eligible for the initial $30B rapid distribution.

    • Payments to practices that are part of larger medical groups will be sent to the group's central billing office.
      • All relief payments are made to the billing organization according to its Taxpayer Identification Number (TIN).
    • As a condition to receiving these funds, providers must agree not to seek collection of out-of-pocket payments from a COVID-19 patient that are greater than what the patient would have otherwise been required to pay if the care had been provided by an in-network provider.
    • This quick dispersal of funds will provide relief to both providers in areas heavily impacted by the COVID-19 pandemic and those providers who are struggling to keep their doors open due to healthy patients delaying care and cancelled elective services.
    • If you ceased operation as a result of the COVID-19 pandemic, you are still eligible to receive funds so long as you provided diagnoses, testing, or care for individuals with possible or actual cases of COVID-19. Care does not have to be specific to treating COVID-19. HHS broadly views every patient as a possible case of COVID-19.

    How are payment distributions determined

    • Providers will be distributed a portion of the initial $30 billion based on their share of total Medicare FFS reimbursements in 2019. Total FFS payments were approximately $484 billion in 2019.
    • A provider can estimate their payment by dividing their 2019 Medicare FFS (not including Medicare Advantage) payments they received by $484,000,000,000, and multiply that ratio by $30,000,000,000. Providers can obtain their 2019 Medicare FFS billings from their organization's revenue management system.
    • As an example: A community hospital billed Medicare FFS $121 million in 2019. To determine how much they would receive, use this equation:
      • $121,000,000/$484,000,000,000 x $30,000,000,000 = $7,500,000

    What to do if you are an eligible provider

    • HHS has partnered with UnitedHealth Group (UHG) to provide rapid payment to providers eligible for the distribution of the initial $30 billion in funds.
    • Providers will be paid via Automated Clearing House account information on file with UHG or the Centers for Medicare & Medicaid Services (CMS).
      • The automatic payments will come to providers via Optum Bank with "HHSPAYMENT" as the payment description.
      • Providers who normally receive a paper check for reimbursement from CMS, will receive a paper check in the mail for this payment as well, within the next few weeks.
    • Within 30 days of receiving the payment, providers must sign an attestation confirming receipt of the funds and agreeing to the terms and conditions of payment. The portal for signing the attestation will be open the week of April 13, 2020, and will be linked on this page.
    • HHS' payment of this initial tranche of funds is conditioned on the healthcare provider's acceptance of the Terms and Conditions - PDF, which acceptance must occur within 30 days of receipt of payment. Not returning the payment within 30 days of receipt will be viewed as acceptance of the Terms and Conditions. If a provider receives payment and does not wish to comply with these Terms and Conditions, the provider must do the following: contact HHS within 30 days of receipt of payment and then remit the full payment to HHS as instructed.  Appropriate contact information will be provided soon.

    Is this different than the CMS Accelerated and Advance Payment Program?

    Yes. The CMS Accelerated and Advance Payment Program has delivered billions of dollars to healthcare providers to help ensure providers and suppliers have the resources needed to combat the pandemic. The CMS accelerated and advance payments are a loan that providers must pay back. 

    Priorities for the remaining $70 billion

    Targeted distributions are being worked on that will focus on providers in areas particularly impacted by the COVID-19 outbreak, rural providers, providers of services with lower shares of Medicare reimbursement or who predominantly serve the Medicaid population, and providers requesting reimbursement for the treatment of uninsured Americans.

    Other CARES Act Sections Relevant to Laboratories and Diagnostics Providers

    Section 3709 - Increasing Provider Funding through Immediate Medicare Sequester Relief

    • This section provides prompt economic assistance to health care providers on the front lines fighting the COVID-19 virus, helping them to furnish needed care to affected patients. Specifically, this sectionwould temporarily lifts the Medicare sequester, which reduces payments to providers by 2%, from May 1 through December 31, 2020, boosting payments for hospital, physician, nursing home, home health, and other care. The Medicare sequester will be extended by one year beyond current law to provide immediate relief without worsening Medicare’s long-term financial outlook.

    Section 3716 - Clarification Regarding Uninsured Individuals

    • This section clarifies a section of the Families First Coronavirus Response Act of 2020 (Public Law 116-127) by ensuring that uninsured individuals can receive a COVID-19 test and related service with no cost-sharing in any state Medicaid program that elects to offer such enrollment option.

    Section 3717 - Clarification Regarding Coverage of Tests

    • This section clarifies a section of the Families First Coronavirus Response Act of 2020 (Public Law 116-127) by ensuring that beneficiaries can receive all tests for COVID-19 in Medicare Part B with no cost-sharing.

    Section 3718 - Preventing Medicare Clinical Laboratory Test Payment Reduction

    • This section prevents scheduled reductions in Medicare payments for clinical diagnostic laboratory tests furnished to beneficiaries in 2021. It also delays by one year the upcoming reporting period during which laboratories are required to report private payor (PAMA) data.

    You can see the full Bill, here.

    CMS has issued a Fact Sheet with more information: Expansion of the Accelerated and Advance Payments Program for Providers and suppliers During COVID-19 Emergency 

    The American Clinical Laboratory Association (ACLA) has issued a statement criticizing the Act's failure to assure fair reimbursement for testing efforts. You can read it and related statements on the association's COVID response efforts page.

    COVID-19 Billing Resources and Updates


    CPT Coding Guidance and SARS-CoV-2 Test Reporting

    ICD-10 coding for
    COVID-19 FAQ

    Medicare Administrative Contractor (MAC) COVID-19 Test Pricing

    Health Insurance Providers Respond to Coronavirus

    Testing Resources, Lab Collaboration Info, and Advocacy Updates

    Testing Resources for
    COVID-19

    Additional Laboratory Resources


    COVID-19 Tracking Project Testing Data by State

    Private Sector Collaboration and Resources

    Interim Guidance and Resources for Laboratory Professionals

    COVID-19 Testing Volumes and Advocacy Efforts

    COVID-19 Business Intelligence, Briefings, and Analysis

    Federal Funding Available for Labs Developing COVID-Related Tests

    Supplies Needed for COVID-19 Testing

    XIFIN is organizing a "Call For Action" to laboratories that are not performing COVID-19 testing who may have extra inventory of specimen collection swabs and transport media, and who are willing to sell them to laboratories that need them. Click to see the full list of needed supplies and direct contact information.

    Learn More

    COVID-19: Steps XIFIN Is Taking

    With the Coronavirus Disease 2019 (COVID-19) continuing its spread around the world, we at XIFIN recognize the responsibility we have to our employees, customers, and partners during this critical time. The health and well-being of our team, our clients, and our clients’ employees are of the utmost importance to us.

    As a critical partner to your business, we understand that limiting the impact of this health event on our service is imperative. We are keenly focused on our business continuity planning efforts to maintain a safe work environment for our associates and to sustain our business operations.

    Security and safety are integral to our products, business processes, and infrastructure. We have a robust, global, integrated Business Continuity Program in place that is managed by a dedicated team of experts who are working hard to keep our operations running smoothly so that we can provide you with the best possible service.

    As such, we have activated our Business Continuity Plan, which includes:

    • Enabling work from home capabilities
    • Deploying a global strategy to coordinate the delivery of services and support to our clients
    • Providing our teams with information and best practices to prevent the spread of any illness
    • Coordinating global and local communications with our employees, clients, and partners
    • Limiting all non-essential business travel
    • Initiated voluntary employee testing

    XIFIN has initiated its own employer-testing protocol for employees who have been deemed essential personnel. Partnering with a leading California laboratory and XIFIN’s health insurer, voluntary testing was offered to XIFIN employees by physician order. With plans in place to maintain a routine COVID-19 and antibody testing program for its employees, XIFIN’s framework can act as a model to enable the type of monitoring that will maintain employee and public confidence.

    We will continue to monitor this fluid situation and will shift workloads as necessary to do what we can to ensure essential services remain fully operative. XIFIN has demonstrated support to our clients in past emergency situations, and in dealing with the present circumstances, we remain unwavering in our efforts to deliver essential services to all our clients. We are keeping those directly affected by this virus in our thoughts, and send our best wishes for health and safety.