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 IndexCOVID-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
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.
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
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]
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 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). Diagnostic COVID-19 related laboratory tests (other than COVID-19 test)
| 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. 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:
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. 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 | 86328, 86413, 86769, 87426, 87635, 87811, 0224U, C9803, G2023, G2024, U0001, U0002, U0003, U0004 | |
| Alaska | 86328, 86769, 87635, U0001, U0002, U0003, U0004 | |
| Arizona | 86328, 86769, 87426, 87635, C9803, G2023, G2024, U0001, U0002, U0003, U0004 | |
| Arkansas | 87635 | |
| California | 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
Coding and billing for a COVID-19 screening test for an asymptomatic essential worker
To avoid denials:
Member financial responsibility for this type of test
Delegated provider financial responsibility for this type of test
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. | 86328, 86769, 87426, 87635, 0224U, C9803, G2023, G2024, Modifier 32 |
| Colorado | U0001, U0002, U0003, U0004, 86328 , 86769, 87635 | |
| Connecticut | U0001, U0002, U0003, U0004, 86328 , 86769, 87635 | |
| Delaware | U0001, U0002, U0003, U0004, 86328 , 86769, 87635, G2023, G2024 | |
| District of Columbia | 87635, 0240U, 87636, 0241U, 87637, U0003, U0004, 86328, 86769, 87426, 87811, 0225U | |
| Florida | 86328, 86408, 86409, 86769, 87635, 87426, 0202U, 0223U, 0224U, 0226U, C9803, G2023, G2024, U0002, U0003, U0004 | |
| Georgia | U0001, U0002, U0003, U0004, 86328 , 86769, 87635 | |
| Hawaii | 86328, 86769, 87426, 87811, 87428, 87635, 87636, 87637, 0240U, 0241U, C9803, G2023, G2024, U0001, U0002, U0003, U0004 | |
| Idaho | 86328, 86408, 86409, 86769, 87426, 87635, 87636, 87637, 87811, 0202U, 0223U, 0224U, 0225U, 0226U, G2023, G2024, U0002, U0003, U0004 | |
| Illinois | 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 | 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 | 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 | 87635, C9803, G2023, G2024, U0001, U0002, U0003, U0004, CS Modifier | |
| Michigan | 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
| 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
|
| Mississippi | BCBS of Mississippi added U0005: | 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. | 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. 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:
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. | 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:
| 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 | 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:
| 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. | 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:
| 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. | 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 | 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:
| 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 | 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 |
| 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
- Medical review contractors will consider diagnostic test order requirements met if there’s:
- 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.
- Page 17
- https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf
- 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
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, U0005 |
| 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. 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. ——— 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
| 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. | 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 | 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 | 3/22/21: Rate decrease for HCPCS codes U0003 and U0004 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 | 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, U0005, 87635, G2023, G2024, |
| 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. | 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, U0005, 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 | 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, U0005 |
| 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 | 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
- If already enrolled in Medicare as the following provider type, no action is needed to administer and bill for COVID-19 vaccine (https://www.cms.gov/files/document/covid-19-vaccine-enrollment-scenario-1.pdf).
| Institutional | Non-Institutional |
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- If already enrolled in Medicare as the following provider type(s), you must separately enroll as an institutional or non-institutional provider type, as a mass immunizer, to bill for the administration of COVID-19 vaccine (https://www.cms.gov/files/document/covid-19-vaccine-enrollment-scenario-2.pdf).
| Institutional | Non-Institutional | Durable Medical Equipment (DME) |
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- 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.
- Contact your MAC specific COVID-19 Hotline with the following information (https://www.cms.gov/files/document/covid-19-mac-hotlines.pdf)
- 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.
- To become a centralized biller, call Novitas at 1-855-247-8428 with this information:
- 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.
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
- Electronic Claims
- PC ACE billing software to submit directly to your MAC. Download this free billing software (PDF) from your MAC and electronically submit professional claim roster billing.
- Paper Claims
- Health Insurance Claim Form (CMS-1500) (PDF)
- Roster form for patients (contact your MAC (PDF) for this form)
- Centralized Billing (If you are enrolled as a centralized biller, operating in at least 3 MAC jurisdictions), you can submit professional claims to Novitas, regardless of where you administer the vaccines.
- Electronic 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
- Roster billing can be used if administering vaccine to at least 5 patients on same date of service unless institution is an inpatient 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
- Medicaid COVID-19 Vaccine Enrollment Contact Information (https://www.cms.gov/files/document/medicaid-covid-19-vaccine-enrollment-contact-information.pdf).
State Health Department websites
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.
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.
- sba.gov (application at https://covid19relief.sba.gov/#/)
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.
- 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.
- 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
Additional Laboratory Resources
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.
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:
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.
