Chargemaster Guide for the COVID-19 Public Health Emergency: Part 2 Laboratory Public Health Emergency CDM topics

This blog is a segment from our multi-part “ChargeAssist Update News” resource guide summarizing common charging, coding, and regulatory updates currently being addressed by Chargemaster and Revenue Cycle teams under the current public health emergency period. Proactive monitoring of CMS and other payer coding and claims requirements is more essential now than ever to ensure correct charging, billing and payments.

Codes for COVID-19 Testing

AMA’s initial CPT code for COVID-19 testing was released 3/13/20 with two new codes announced on 4/10/20 codes which can now be billed in addition to new HCPCS Level II codes. More codes have been released by both CPT and CMS since those early days of the outbreak. As noted in one of the early versions of CMS’ COVID-19 FAQ document, there are both HCPCS Level II codes available (U0001 for the CDC Diagnostic Panel test and U0002 for other non-CDC testing) as well as 87635 for the DNA or RNA test by amplified probe technique. Initially, hospitals were confused about whether the CMS codes were designed to be override, Medicare only codes. This was later clarified in documentation from both AMA and CPT that they were for different testing methodologies and purposes.

CMS established HCPCS code U0001 to describe the Centers for Disease Control and Prevention’s (CDC’s) 2019-nCoV Real-Time RT-PCR Diagnostic Panel. The test can be reported by any CDC-qualified lab in the U.S. to enable appropriate tracking and payment for the lab test. Code details are listed below:

  • U0001
    • Long Description- CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel
    • OPPS SI=A
    • Effective Date  2/04/20
    • H&A Auditor notes: HCPCS U0001 is a Real-Time RT-PCR Diagnostic Panel assay developed by the CDC. Only facilities performing the CDC assay may assign this code. Note this is a panel test. “RT-PCR” is the abbreviation for “Reverse Transcriptase-Polymerase Chain Reaction”.

Two additional codes for reporting Coronavirus tests were established in the days following the release of U0001 (one by AMA as a CPT-4 code, and another by CMS as a HCPCS Level II code):

  • U0002
    • Long Description: 2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC
    • OPPS SI=A
    • Effective Date 2/04/20
    • H&A Auditor notes: HCPCS U0002 allows laboratories and healthcare facilities to bill Medicare for validated, in-house developed Covid-19 tests. By code definition, the test must detect multiple types or subtypes. This code should not be used for CDC testing.
  •  87635
    • Long Description- 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 
    • OPPS SI=A
    • Effective Date 3/13/20
    • H&A Auditor notes: CPT 87635 represents a DNA polymerase chain reaction (PCR) assay.

PCR is a method used in molecular biology to rapidly make copies and amplify a DNA sample, and requires specific laboratory equipment, reagents, and testing processes. Additional details about this test are referenced in a special AMA CPT Assistant linked later in this section.

  • In an AMA Fact Sheet entitled “Reporting Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Laboratory Testing” the procedure details for the use of 87635 is: “Place specimens (e.g., nasopharyngeal or oropharyngeal swab, sputum, lower respiratory tract aspirate, bronchoalveolar lavage, and nasopharyngeal wash or aspirate or nasal aspirate) into specimen-transport containers. Use oligonucleotide primers and probes for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (formally known as 2019-nCoV), and any pan-coronavirus types or subtypes if included, to identify viral gene target(s). Isolate and purify ribonucleic acid (RNA) from the specimens, followed by molecular amplification and analysis. Send the test result (positive, negative, inconclusive) to the patient’s physician or other QHP and report or refer to the appropriate public health officials, as indicated.”

As a reminder, AMA as well as CMS have stated that if a more specific CPT lab testing code is available, it should be used rather than the U range HCPCS level II coding.

Both AMA and CMS have been continuing to create codes for lab tests for COVID-19 as clinical laboratories, hospital groups and academic medical centers are developing their own tests in-house.

Antibody Tests

In mid-April, AMA released updates to the Immunology testing section to allow for two new codes for COVID-19 antibody testing as tests were approved by the FDA.

Antibody tests identify patients that have developed an immune response to COVID-19. As of this time, COVID-19 antibody testing is still being evaluated for its efficacy; and, unfortunately has resulted in numerous false-negative results. It is hoped that these tests will play a role in determining the prevalence of COVID-19 in geographic areas, help determine the infection rate (including asymptomatic individuals), and help identify those who could safely return to normal activities.

CPT has noted that its new codes are specific for COVID-19. 86328 is a child code to 86318. 86769 is for the antibody test for COVID-19 using a multiple-step method. This code is a child code to existing code 86710.

In support of the new code 86328, the description for parent code 86318 was revised with the term antibody(ies) to allow for testing for multiple infectious agent antibodies, and a semi colon is added to the end to accommodate the new child code’s addition. Here is a summary of the three codes that were updated in this code family:

86318 Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single step method (eg, reagent strip)

  • Description Change – Code revised with the term antibody(ies), and a semi-colon has been added to the end to accommodate the new child code 86328.

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])

  • New Immunology Code, Child to 83618, Resequenced code

86769 – Antibody; severe acute respiratory syndrome coronavirus 2 (SARS_CoV-2) (Coronavirus disase [COVID-19])

  • New Immunology Code

Two special editions of AMA CPT Assistants provide more clinical details for use of the COVID-19 laboratory testing codes: https://www.ama-assn.org/system/files/2020-03/cpt-assistant-guide-coronavirus.pdf and https://www.ama-assn.org/system/files/2020-04/cpt-assistant-guide-coronavirus-april-2020.pdf.

“High-Throughput” Lab Tests

In an April 14 CMS Rulings document (CMS-Ruling 2020-01-R) CMS identifies certain COVID-19 tests classified as “high throughput” testing for increased payment. Unlike Transmittals, Medlearn Matters, or FAQs, CMS Rulings are “decisions of the Administrator that serve as precedent final opinions and orders and statements of policy and interpretation. They provide clarification and interpretation of complex or ambiguous statutory or regulatory provisions relating to Medicare, Medicaid, Utilization and Quality Control Peer Review, private health insurance, and related matters. They are published under the authority of the Administrator of the Centers for Medicare & Medicaid Services (CMS).”

As noted in the Rulings document linked here: https://www.cms.gov/files/document/cms-2020-01-r.pdf “A high throughput technology uses a platform that employs automated processing of more than two hundred specimens a day.” CMS has noted that “these tests require more intensive technician training (to ensure the role of extremely skilled personnel) and more time intensive processes (to assure quality)”. According to CMS, examples of high throughput technology 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.

CMS later confirmed that providers do not have to perform the 200 specimen quantity per day, to utilize these codes. This clarification was to differentiate the tests themselves, not establish a mandated testing volume for providers.

Medicare will pay laboratories for the “high throughput” tests at $100 on or after April 18, 2020 (previously paid by MACs at approximately $51 under Medicare Part B Clinical Laboratory Fee Schedule) through the duration of the COVID-19 national emergency. The CMS press release on these tests is noted here: https://www.cms.gov/newsroom/press-releases/cms-news-alert-april-16-2020.

CMS’s new codes for these tests include:

  • 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

The Rule states that “U0003 should identify tests that would otherwise be identified by CPT code 87635 but for being performed with these high throughput technologies” and “U0004 should identify tests that would otherwise be identified by U0002 but for being performed with these high throughput technologies.” CMS also notes that “neither U0003 nor U0004 should be used for tests that detect COVID-19 antibodies.”

As for payments to expect, CMS has stated in the Ruling that it will pay for the following tests at a rate of $100 “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.”

Investigational COVID-19 Immunotherapy Treatment

FDA has provided a website with information on the use of donated plasma from fully-recovered COVID-19 patients to obtain specific antibodies. The term for this treatment is “Convalescent Plasma Therapy” which is only recently becoming performed in an attempt to treat COVID-19 positive patients.

Hospitals are now struggling to confirm just what they can bill for if collecting the plasma from the recovered patients or for administering this product to those who may benefit. Because COVID-19 convalescent plasma treatments have not yet been formally approved for use by FDA, they are regulated as investigational and the current use is being allowed under specifically defined FDA pathways during the Public Health Emergency period. We suggest contacting your MAC and commercial payers to confirm claims requirements and coverage if these therapies are being planned.

COVID-19 Convalescent Plasma (CCP) Details

  • Until there are more specific codes approved, hospitals and blood banks would likely utilize HCPCS P9099 –blood component or product not otherwise classified. CCP is not a typical plasma product, so we anticipate a more specific code from CMS. If this is a new charge, be certain to consider pricing development carefully. The cost of screening for eligible donors will make it a very expensive product that looks to be irradiated and treated as part of processing.

“FDA has issued guidance to provide recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency.

Because COVID-19 convalescent plasma has not yet been approved for use by FDA, it is regulated as an investigational product.  A health care provider must participate in one of the pathways described below.  FDA does not collect COVID-19 convalescent plasma or provide COVID-19 convalescent plasma.  Health care providers or acute care facilities would instead obtain COVID-19 convalescent plasma from an FDA-registered blood establishment.”

The guidance provides recommendations on the following:

*… “given the public health emergency that the COVID-19 pandemic presents, while clinical trials are being conducted and an expanded access protocol is available, FDA also is facilitating access to COVID-19 convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections through the process of the patient’s physician requesting a single patient emergency IND (eIND) for the individual patient under 21 CFR 312.310. This process allows the use of an investigational drug for the treatment of an individual patient by a licensed physician upon FDA authorization, if the applicable regulatory criteria are met.  Note, in such case, a licensed physician seeking to administer COVID-19 convalescent plasma to an individual patient must request the eIND (see 21 CFR 312.310(b)).”

Collection & Handling for COVID-19 Laboratory Testing Collection

Two codes were announced at the end of March by CMS for reporting Coronavirus test collection. CMS assigned OPPS Status Indicator N for these codes and communicated with us directly on our questions about the intent of the codes’ use. The Integrated Outpatient Code Editor (I/OCE) Specifications Version 21.1V2 update was retroactive to 3/1/20 and was appended with these new codes.

  • 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 SNF or by a laboratory on behalf of a HHA, any specimen source

For a review of CMS explanation of these codes, see the Interim Final Rule 3/31/20 section M. “Medicare Clinical Laboratory Fee Schedule: Payment for Specimen Collection for Purposes of COVID-19 Testing”. CMS states that these codes are designed to report COVID-19 testing for “homebound and non-hospital inpatients” (see page 94 of the Display Copy of the IFR document). The rates for these codes are: $23.46 for G2023 and $25.46 for G2024 under the clinical laboratory fee schedule system. However, because the codes are assigned OPPS Status Indicator N, it currently appears that there would be no separate payment for facility billing under OPPS. CMS is currently aware that there are industry questions about the use and payment system treatment of these codes beyond the locations noted in the IFR.

CMS says that “not more than one such fee may be provided with respect to samples collected in the same encounter”. CMS notes that “Neither the annual cash deductible nor the 20 percent coinsurance for Medicare apply to either specimen collection fees or travel allowance for lab tests”.

CMS also notes that “Medicare allows payment for a specimen collection fee when it is medically necessary for a laboratory technician to draw a specimen from either a nursing home patient or homebound patient” and that “the technician must personally draw the specimen.” It also states that “this fee will not be paid to anyone who has not extracted the specimen”. For future reference, CMS has stated “If in the future other types of COVID-19 tests are available, such as serological tests or point of care tests, we note that the specimen collection fee would apply if the specimen collection method must be performed by trained laboratory personnel. However, COVID-19 tests that allow patients to collect the specimen themselves would not be eligible for the specimen collection fee.” Also, it may be helpful to review the IRF discussion on ‘who is homebound’ for this benefit (page 99 of the display copy).

Note that if your hospital is providing these services as specified in the regulations, there is also an opportunity to bill for transportation to perform the collection. As noted in the IFR (page 93 of the display copy) Section 1833(h)(3)(B) of the Act requires the Secretary to provide for and establish a fee to cover the transportation and personnel expenses for trained personnel to travel to the location of an individual to collect the sample, except that such a fee may be provided only with respect to an individual who is homebound or an inpatient in an inpatient facility (other than a hospital). In accordance with this provision, Medicare established a travel allowance for a laboratory technician to draw a specimen from homebound patients and non-hospital inpatients.”… This fee is “paid only when the nominal specimen collection is also payable and is not available if the technician is merely performing a messenger service to pick a specimen drawn by a physician or nursing home personnel”. Medicare Part B MACs calculate the travel allowance for each claim. Note that these two codes are assigned OPPS SI A with no current I/OCE edits. The applicable codes are:

  • P9603 – Travel allowance one way in connection with medically necessary laboratory specimen collection drawn from home bound or nursing home bound patient; prorated miles actually travelled
  • P9604 Travel allowance one way in connection with medically necessary laboratory specimen collection drawn from home bound or nursing home bound patient; prorated trip charge

Waived Test Modifier

CMS released a One Time Notification (Transmittal 10066/ CR 11765) dated 4/24/20 that the -QW modifier should be added to MACs systems for Part B billing of codes U0002 and 87635 effective 3/20/20. CMS Business Requirements state that the Medicare Contractor shall permit use of the U0002QW and 87635QW for claims submitted by testing providers with a valid, current CLIA certificate of waiver with dates of service on or after March 20, 2020. CMS notes that Contractors “need not search their files to either retract payment for claims already paid or to retroactively pay claims. However, contractors shall adjust claims brought to their attention.”  

What’s Next for Laboratory Chargemaster Management?

Laboratory departments will need to stay vigilant for additional AMA and CMS updates for COVID test coding as well as other regulatory changes during the Public Health Emergency period. We suggest monitoring CMS transmittals, MLN Matters articles, and the FAQs that are being updated as clarifications occur. (See Part 1 of our Guide for URLs of helpful websites.)

Quarterly CDM updates to coding, payment systems, and editing files for CMS must continue for ongoing data integrity and accurate claims. CDM updates often require the expertise of Clinical Laboratory team members with staffing stretched thin during this time.

Significant regulatory mandates such as Protecting Access to Medicare Act (PAMA) commercial insurance rate reporting for laboratories and Price Transparency requirements have kept hospital Revenue Cycle teams busy over the past few years. Congress passed and President Trump signed into law the Laboratory Access for Beneficiaries (LAB) Act as part of the 2020 spending bill. The move delays the next reporting cycle for PAMA to 2021. As of this time, the expanded Chargemaster and Shoppable Services Price Transparency mandates (based on Executive Order) have not been postponed.

And finally, internal initiatives such as system conversions, changes to reference laboratories, or compliance auditing and monitoring may also be underway or planned. If so, data updates and file management will remain critical tasks for these special projects.

If your team needs an audit of your current CDM or Laboratory files by our Laboratory technical auditors, please reach out. We can provide pricing for a remote Laboratory-specific CDM Review engagement with quick turnaround and web-based working sessions to discuss our findings.

Part I of this series linked below provides many CMS and AMA reference and COVID news links: https://www.chargeassist.com/chargemaster-guide-for-covid-19/

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Author: Rosemary Holliday, MHA, Managing Partner, Holliday & Associates/ ChargeAssist

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