COVID-19 Diagnostic Laboratory Screening/Testing - Body
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
COVID-19 Diagnostic Laboratory Screening/Testing
Policy Number: PG0469 ADVANTAGE | ELITE | HMO
Last Review: 02/01/2021 INDIVIDUAL MARKETPLACE |
PROMEDICA MEDICARE
PLAN | PPO
GUIDELINES
This policy does not certify benefits or authorization of benefits, which is designated by each individual
policyholder contract. Paramount applies coding edits to all medical claims through coding logic software
to evaluate the accuracy and adherence to accepted national standards. This guideline is solely for
explaining correct procedure reporting and does not imply coverage and reimbursement.
SCOPE
This policy applies to following lines of business: HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare
Plan, Advantage
X Professional
X Facility
This policy applies to inpatient and outpatient laboratory services required for treatment of members suspected with
or diagnosed with COVID-19.
DESCRIPTION
Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe
diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome
(SARS-CoV). The World Health Organization (WHO) and The Centers for Disease Control and Prevention (CDC)
are actively monitoring the outbreak of this new coronavirus strain.
The WHO and the CDC indicated that COVID-19 is a new disease, a new strain of coronavirus which originated in
Wuhan City, China, The CDC documents they are still learning how it spreads, the severity of illness it causes, and
to what extent it may spread in the United States.
Description of COVID-19, as identified today
COVID-19 mainly spreads person-to-person
o Between people who are in close contact with one another (within about 6 feet).
Close personal contact such as touching or shaking hands.
o Through respiratory droplets produced when an infected person coughs or sneezes.
These droplets can land in the mouths or noses of people who are nearby or possible be
inhaled into the lungs.
People are thought to be most contagious when they are most symptomatic (the sickest).
Some spread might be possible before people show symptoms; there have been reports of this occurring
with this new coronavirus, but this is not thought to be the main way the virus spreads.
It may be possible that a person can get COVID-19 by touching a surface or object that has the virus on it
and then touching their own mouth, nose, or possibly their eyes, but this is not thought to be the main way
the virus spreads.
The virus that causes COVID-19 seems to be spreading easily and sustainably in the community
(“community spread”) in some affected geographic areas.
Symptoms:
Anyone can have mild to severe symptoms.
Older adults and people who have severe underlying medical conditions like heart or lung disease or
diabetes seem to be at higher risk for developing more serious complications from COVID-19 illness.
Persons with weakened immune systems are at higher risk for more severe symptoms for this illness.
PG0469 – 02/01/2021People with COVID-19 have had a wide range of symptoms reported – ranging from mild symptoms to severe
illness. Symptoms may appear 2-14 days after exposure to the virus. People with these symptoms may have
COVID-19, may not be an all-inclusive list:
Fever or Chills
Cough
Shortness of breath/breathing difficulties
Fatigue
Muscle or body aches
Headache
New loss of taste or smell
Sore throat
Congestion or runny nose
Nausea or vomiting
Diarrhea
Rash
Inflammatory conditions such as “COVID toes”
Thromboembolic events
Trouble breathing
Bluish lips or face
Persistent pain or pressure in the chest
New confusion or other alterations in mental status
Alterations in blood glucose control
Inability to wake or stay awake
Children with multisystem inflammatory syndrome
Members are directed to call their healthcare provider for medical advice when there has been exposure to COVID-
19 and have developed the symptoms listed above.
If a member develops emergency warning signs for COVID-19, they should get medical attention immediately.
Emergency warning signs include, not all-inclusive:
Difficulty breathing or shortness of breath
Persistent pain or pressure in the chest
New confusion or inability to arouse
Bluish lips or face
Mildly ill patients are encouraged to stay home and contact their healthcare provider by phone for guidance about
clinical management. Older patients and individuals who have underlying medical conditions or are
immunocompromised should contact their physician early in the course of even mild illness.
Testing:
Clinicians are to work with their local and state health departments to coordinate testing through public health
laboratories. In addition, COVID-19 diagnostic testing, authorized by the Food and Drug Administration under an
Emergency Use Authorization (EUA), is becoming available in clinical laboratories. This additional testing capacity
will allow clinicians to consider COVID-19 testing for a wider group of symptomatic patients.
Clinicians are to rely upon the best-available clinical guidelines and policy recommendations offered by multiple
medical and public health organizations, including but not limited to the CDC, FSA, AMA, IDSA, WHO. Respiratory
viral panel testing in the outpatient setting using limited panels involving five (5) targets or less is considered
medically necessary for individuals who are at high risk for complications of respiratory viral infection, including but
not limited to individuals who are immunocompromised, including lung transplant recipients, when the result of
testing is used to guide or alter management.
Clinicians are utilizing their medical judgment to determine if a patient has signs and symptoms compatible with
COVID-19 and whether the patient should be tested. Clinical decisions about testing are made by the individual’s
attending health care provider and may include testing of individuals with signs or symptoms compatible with
COVID-19, as well as asymptomatic individuals with known or suspected recent exposure to SARS-CoV-2, that is
PG0469 – 02/01/2021determined to be medically appropriate by the individual’s health care provider, consulting CDC guidelines as
appropriate. Most patients with confirmed COVID-19 have developed fever and/or symptoms of acute respiratory
illness (e.g., cough, difficulty breathing). Priorities for testing may include:
1. Hospitalized patients who have signs and symptoms compatible with COVID-19 in order to inform decisions
related to infection control.
2. Testing should be based on the local epidemiology of COVID-19, as well as the clinical course of illness.
Most patients with confirmed COVID-19 have developed fever (subjective or confirmed) and/or symptoms of
acute respiratory illness (e.g., cough, difficulty breathing);
3. Other symptomatic individuals such as, older adults and individuals with chronic medical conditions and/or
an immunocompromised state that may put them at higher risk for poor outcomes (e.g., diabetes, heart
disease, receiving immunosuppressive medications, chronic lung disease, chronic kidney or liver disease).
4. Any persons including healthcare personnel, who within 14 days of symptom onset had, close contact with
a suspect or laboratory-confirmed COVID-19 patient.
5. Any persons with a history of travel from affected geographic areas with sustained/ongoing transmission
(Level 2 or 3-travel health notice.
There are epidemiologic factors that may also help guide decisions about COVID-19 testing. Documented COVID-
19 infections in a jurisdiction and known community transmission may contribute to an epidemiologic risk
assessment to inform testing decisions. Clinicians are strongly encouraged to test for other causes of respiratory
illness (e.g., influenza).
Prevention: Standard recommendations to prevent infection spread include:
Avoid large events and mass gatherings.
Avoid close contact (within about 6 feet, or 2 meters) with anyone who is sick or has symptoms.
Stay home as much as possible and keep distance between yourself and others (within about 6 feet, or 2
meters), especially if you have a higher risk of serious illness. Keep in mind some people may have COVID-
19 and spread it to others, even if they do not have symptoms or do not know they have COVID-19.
Wash your hands often with soap and water for at least 20 seconds, or use an alcohol-based hand sanitizer
that contains at least 60% alcohol.
Cover your face with a cloth facemask in public spaces, such as the grocery store, where it is difficult to
avoid close contact with others, especially if you are in an area with ongoing community spread.
Cover your mouth and nose with your elbow or a tissue when you cough or sneeze. Throw away the used
tissue. Wash your hands right away.
Avoid touching your eyes, nose and mouth.
Avoid sharing dishes, glasses, towels, bedding and other household items if you are sick.
Clean and disinfect high-touch surfaces, such as doorknobs, light switches, electronics and counters, daily.
Stay home from work, school and public areas if you are sick, unless you are going to get medical care.
Avoid public transportation, taxis and ride-sharing if you're sick
POLICY
Coverage
HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan
Paramount will cover the appropriate medically necessary diagnostic laboratory tests that are
consistent with CDC Guidance related to COVID-19. (U0001, U0002, U0003, U0004, 87635, 86328,
86769, G2023, G2024, 0202U, C9803). Additionally, Effective 6/25/2020 – codes 87426, 0223U,
0224U. Additionally, Effective 8/10/2020 – codes 86408, 86409, 0225U, 0226U.
Advantage
Paramount will cover the appropriate medically necessary diagnostic laboratory tests that are
consistent with CDC Guidance related to COVID-19 and the Ohio Department of Medicaid
coverage determinations. (U0001, U0002, U0003, U0004, 87635, 86328, 86769, G2023, G2024,
0202U, C9803). Additionally, Effective 6/25/2020 – codes 87426, 0223U, 0224U. Additionally,
Effective 8/10/2020 – codes 86408, 86409, 0225U, 0226U. Effective 10/6/2020 – codes 0240U,
0241U, 87636, 87637, and 87811.
PG0469 – 02/01/2021HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan, Advantage
Screening/Testing must be supported by a Physician Order or State Law, or meeting the Health
Department Criteria Screening, performed in an FDA approved facility/laboratory location, in
accordance with CDC guidelines. (86328, 86408, 86409, 86769, 87426, 87635, 87636, 87637, 87811,
0202U, 0223U, 0224U, 0225U, 0226U, 0240U, 0241U, C9803, G2023, G2024, U0001, U0002, U0003,
U0004)
No Prior Authorization required for all Product Lines.
Cost Share/Co-Pay HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan
In adherence with the COVID-19 State of Emergency issued on March 13, 2020, and federal
requirements under the Families First Coronavirus Response Act (FFCRA) and the Coronavirus
Aid, Relief and Economic Security Act (CARES Act), Paramount will TEMPORARILY waive cost-
share (e.g. co-pays and/or deductibles) for diagnostic laboratory testing and the collection of
specimens related to COVID-19. This policy applies to laboratory tests that have been approved
by the FDA or which have followed the emergency use authorization process outlined by the FDA
and are listed on the FDA website.
Expires the expiration of the applicable state of emergency.
COVERAGE CRITERIA
HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan, Advantage
Medically Necessary:
Testing is covered when medically appropriate for the individual, as determined by the individual’s attending health
care provider to be medically appropriate by the individual’s health care, consulting CDC guidelines as appropriate.
Clinical decisions about testing are made by the individual’s attending health care provider and may include:
individuals with signs or symptoms compatible with COVID-19
asymptomatic patients used as part of a pre-surgical or facility pre-admission screening, prior to an
immunosuppressive procedure, or when a patient is admitted to a Skilled Nursing Facility in accordance
with CMS and CDC testing guidelines
asymptomatic individuals with known or suspected recent exposure to SARS-CoV-2
Coronavirus COVID-19 (SARS-CoV-2) respiratory panel (up to 5 respiratory pathogens) test when member
has signs and symptoms of COVID-19
Testing for the COVID-19 virus includes Polymerase Chain Reaction (PCR) testing and serology testing.
Testing/Screening must be supported by a Physician Order or meets the Health Department Criteria Screening,
and done in any approved laboratory location. (86328, 86408, 86409, 86769, 87426, 87635, 87636, 87637, 87811,
0202U, 0223U, 0224U, 0225U, 0226U, C9803, G2023, G2024, U0001, U0002, U0003, U0004, 0240U, 0241U
86328, 86408, 86409, 86769, 87426, 87635, 87636, 87637, 87811, 0202U, 0223U, 0224U, 0225U, 0226U, C9803,
G2023, G2024, U0001, U0002, U0003, U0004, 0240U, 0241U).
Testing is consistent with and members meet the guidelines set forth by the United States Centers for
Disease Control and Prevention (CDC).
PCR test being ordered has been granted a EUA (Emergency Use Authorization) by the FDA or is
otherwise FDA-approved.
Testing must be processed by an FDA-approved lab.
PCR diagnostic testing for COVID-19 is covered, when ordered by an attending health care provider and
provided at the point of care for individuals who are symptomatic and are concerned about infection, for the
purpose of identifying and treating active disease.
Serology (antibody) testing will be covered when medically appropriate for an individual, as determined and
ordered by the individual's attending health care provider, after an evaluation of the individual and in
accordance with accepted standards of current medical practice.
Serology (antibody) testing is not to be used as a sole means of diagnosis of COVID-19 infection.
PG0469 – 02/01/2021 Host antibody serology testing to support a diagnosis of Multisystem Inflammatory Syndrome in Children
(MIS-C) meets coverage criteria.
PCR testing for asymptomatic members exposed to persons with known COVID-19 with a provider order
PCR testing is conducted in a 72-hour window of time preceding planned surgical intervention.
Serial PCR tests to determine when the infection has abated with provider orders.
PCR testing is felt to be a necessary component of clinical decision-making.
When either procedure U0002 or 87635 are submitted on a claim with modifier QW, payment for an approved test
may be made to a provider possessing a CLIA Certificate of Waiver. Without modifier QW, payment may be made
only to a provider possessing a higher-level CLIA Certificate of Registration, Compliance, or Accreditation. In other
words, a lab with a higher-level CLIA certificate may receive payment for performing either a non-waived version of
the test (reported without modifier QW) or a waived version (reported with modifier QW). A lab with only a CLIA
Certificate of Waiver may receive payment only for performing a waived version of the test (reported with modifier
QW).
Procedure U0003 should identify tests that would otherwise be identified by CPT code 87635, but are being
performed with the high throughput technologies.
Procedure U0004 should identify tests that would otherwise be identified by HCPCS code U0002, but are being
performed with the high throughput technologies.
Neither U0003 nor U0004 should be used for tests that detect COVID-19 antibodies (CPT codes 86328 and
86769).
The World Health Organization, IDSA and CDC all concur that antibody testing currently has too many variables
and unknown performance characteristics to be used as the sole method of either establishing a diagnosis of
COVID-19 or confirming immunity. The true rate of cross-reactivity of antibodies from COVID-19 infections to those
antibodies produced by other coronaviruses is unknown. There are several parts of a coronavirus that can produce
antibodies. Which ones are most accurate for predicting recovery and immunity is currently unknown. It is not
known what level of antibodies in a person’s bloodstream is needed to provide immunity, get rid of the virus, and
prevent reinfection. This is important, as individuals who have had a mild case of COVID-19 and initially recover
may not develop enough antibody to prevent a future COVID-19 infection. If antibodies prove to provide immunity,
it is not currently known how long that immunity will last.
There are two types of antibody tests. One is identified as Rapid Detection Testing. It is a qualitative test and is
very similar to a pregnancy test. The result is either positive, negative or inconclusive, but there is no information in
the result about how much antibody a person may have. The second testing type is Enzyme-Linked
Immunosorbent Assay (ELISA). This is a quantitative test. The patient’s antibodies to COVID-19 are mixed with a
colored substrate that binds to the antibodies. The result is read with a special instrument that can identify very
minor variations in color. The more intense the color the more COVID-19 antibody is present. Only this second test
can identify the level of antibody a person has but as noted above, it is not currently known what level of antibody is
needed to protect the person from being infected again by COVID-19.
The CDC notes that with a positive antibody test for COVID-19, "it’s unclear if those antibodies can provide
protection (immunity) against getting infected again." A negative antibody test could mean you have a current
infection and could still spread the virus and CDC specifically notes: "these test results alone do not confirm if you
are able to spread the virus that causes COVID-19." As such, we do not feel that it is in the best interest of the
workforce or public health to promote and perform these tests except on a case-by-case basis with decisions made
by a clinician actively caring for the patient.
Not Medically Necessary:
respiratory Virus Panels which include COVID-19 for screening purposes or asymptomatic individuals or
when more than 5 pathogens are tested regardless of the presence of symptoms
PG0469 – 02/01/2021 SARS-CoV-2 serology (antibody) testing is considered not medically necessary to evaluate current infection
or contagiousness
until more information is available about the dynamics of IgA detection in serum, testing for IgA antibodies is
not recommended.
Testing Limitations and Exclusions/Not Covered (unless mandates otherwise by applicable law), may not be
all-inclusive:
general workplace health and safety
o return to work
o employment
education/school
participation in sports
recreational activities, i.e. camp, social events
admission to educational/residential institutions/correction facilities
routine and/or physicals
travel
court order
other third-party requirements
over-the-counter tests for the diagnosis of COVID-19 infection
testing for public health surveillance purposes
tests that have not been approved for use by the FDA or authorized per FDA EUA guidelines.
CODING/BILLING INFORMATION
The appearance of a code in this section does not necessarily indicate coverage. Codes that are covered may
have selection criteria that must be met. Payment for supplies may be included in payment for other services
rendered.
CPT CODES
Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single step
86328 method (eg, reagent strip); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
(Coronavirus disease [COVID-19]). Effective 4/10/2020 Antibody Testing
Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
86408
(Coronavirus disease [COVID19]); screen. Effective 8/10/2020 Antibody Testing
Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
86409
(Coronavirus disease [COVID19]); titer. Effective 8/10/2020 Antibody Testing
Antibody; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus
86769
disease [COVID-19]). Effective 4/10/2020 Antibody Testing
Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay
[EIA], enzyme-linked immunosorbent assay [ELISA], immunochemiluminometric assay
87426 [IMCA]) qualitative or semiquantitative, multiple-step method; severe acute respiratory
syndrome coronavirus (eg, SARS-CoV, SARSCoV-2 [COVID-19]) Effective 6/25/2020
PCR/Antigen Testing
Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome
87635 coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique.
Effective March 13, 2020 PCR/Antigen Testing
Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome
87636 coronavirus 2 (SARS-CoV-2)(Coronavirus disease [COVID-19]) and influenza virus types A
and B, multiplex amplified probe technique Effective October 6, 2020 PCR/Antigen Testing
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,
87637
and respiratory syncytial virus, multiplex amplified probe technique Effective October 6, 2020
PCR/Antigen Testing
Infectious agent antigen detection by immunoassay with direct optical (ie, visual) observation;
87811 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease
[COVID-19]) Effective October 6, 2020 PCR/Antigen Testing
PG0469 – 02/01/2021HCPCS CODES
SARS-CoV-2/2019-nCoV (COVID-19) CDC laboratory testing. This code is used specifically
U0001
for CDC testing laboratories. Effective February 4, 2020 PCR/Antigen Testing
SARS-CoV-2/2019-nCoV (COVID-19) non-CDC laboratory testing. This code is used for non-
U0002
CDC testing laboratories. Effective February 4, 2020 PCR/Antigen Testing
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,
U0003
making use of high throughput technologies as described by CMS-2020-01-R. Effective
4/14/2020 PCR/Antigen Testing
2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types
U0004 or subtypes (includes all targets), non-CDC, making use of high throughput technologies as
described by CMS-2020-01-R. 4/14/2020 PCR/Antigen Testing
Infectious disease (bacterial or viral respiratory tract infection), pathogen-specific nucleic acid
(DNA or RNA), 22 targets including severe acute respiratory syndrome coronavirus 2 (SARS-
0202U
CoV-2), qualitative RT-PCR, nasopharyngeal swab, each pathogen reported as detected or
not detected. Effective 5/20/2020 PCR/Antigen Testing
Infectious disease (bacterial or viral respiratory tract infection), pathogen-specific nucleic acid
(DNA or RNA), 22 targets including severe acute respiratory syndrome coronavirus 2 (SARS-
0223U
CoV-2), qualitative RT-PCR, nasopharyngeal swab, each pathogen reported as detected or
not detected. Effective 6/25/2020 PCR/Antigen Testing
Antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)(Coronavirus
0224U
disease [COVID-19]), includes titer(s), when performed. Effective 6/25/2020 Antibody Testing
Infectious disease (bacterial or viral respiratory tract infection) pathogen-specific DNA and
RNA, 21 targets, including severe acute respiratory syndrome coronavirus 2 (SARSCoV-2),
0225U
amplified probe technique, including multiplex reverse transcription for RNA targets, each
analyte reported as detected or not detected. Effective 8/10/2020 PCR/Antigen Testing
Surrogate viral neutralization test (sVNT), severe acute respiratory syndrome coronavirus 2
0226U (SARS-CoV-2) (Coronavirus disease [COVID-19]), ELISA, plasma, serum. Effective
8/10/2020 PCR/Antigen Testing
Infectious disease (viral respiratory tract infection), pathogen-specific RNA, 3 targets (severe
acute respiratory syndrome coronavirus 2 [SARS-CoV-2], influenza A, influenza B), upper
0240U
respiratory specimen, each pathogen reported as detected or not detected. Effective October
6, 2020 PCR/Antigen Testing
Infectious disease (viral respiratory tract infection), pathogen-specific RNA, 4 targets (severe
acute respiratory syndrome coronavirus 2 [SARS-CoV-2], influenza A, influenza B, respiratory
0241U
syncytial virus [RSV])), upper respiratory specimen, each pathogen reported as detected or
not detected. Effective October 6, 2020 PCR/Antigen Testing
Specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-
G2023 2)(Coronavirus disease [COVID-19}), any specimen source. Effective March 1, 2020
PCR/Antigen Testing
Specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-
G2024 2)(Coronavirus disease [COVID-19]), from an individual in a SNF or by a laboratory on behalf
of a HHA, any specimen source. Effective March 1, 2020 PCR/Antigen Testing
Hospital outpatient clinic visit specimen collection for severe acute respiratory syndrome
C9803 coronavirus 2 (sars-cov2) (coronavirus disease [covid-19]), any specimen source
PCR/Antigen Testing
ICD-10
2019-nCoV acute respiratory disease. (Claims for CONFIRMED cases related to COVID-19
U07.1
for dates of service April 1, 2020 and after)
Other coronavirus as the cause of diseases classified elsewhere. CONFIRMED COVID-19
B97.29
CASES
Encounter for observation for suspected exposure to other biological agents ruled out.
Z03.818 (EXPOSURE TO COVID-19, Claims for possible exposure to COVID-19 that is ruled out after
evaluation.)
PG0469 – 02/01/2021Contact with and (suspected) exposure to other viral communicable diseases. (EXPOSURE
Z20.828
TO COVID-19, Claims for exposure to someone with a confirmed case of COVID-19.)
Encounter for screening for other viral diseases. (Claims for asymptomatic members who are
Z11.59 being screened for COVID-19 and have no known exposure to the virus, and the test results
are either unknown or negative.)
Non-Covered ICD-10 diagnosis codes, not all-inclusive
Z02.0 Encounter for examination for admission to educational institution
Z02.1 Encounter for pre-employment examination
Z02.2 Encounter for examination for admission to residential institution
Z02.3 Encounter for examination for recruitment to armed forces
Z02.5 Encounter for examination for participation in sport
Z02.6 Encounter for examination for insurance purposes
Z02.71 Encounter for disability determination
Z02.79 Encounter for issue of other medical certificate
Z02.89 Encounter for other administrative examinations
Z02.9 Encounter for administrative examinations, unspecified
Z11.9 Encounter for screening for other infectious and parasitic diseases
Modifier
QW CLIA waived test
Background History
Effective for dates of service on or after February 4, 2020, Centers for Medicare and Medicaid Services
(CMS) has developed Healthcare Common Procedure Coding System (HCPCS) billing codes, U0001 and
U0002 to bill for tests and track new cases of the virus. Code U0001 may be used for CDC testing
laboratories. Code U0002 may be used for tests established by laboratories that develop their own
validated COVID-19 diagnostics when submitting claims to Medicare or health insurers.
Effective for dates of service on or after March 1, 2020, the Centers for Medicare and Medicaid Services
(CMS) has also established Healthcare Common Procedure Coding System (HCPCS) billing codes, G2023
and G2024 to identify and reimburse specimen collection for COVID-19 testing. These codes are billable
and separately reimbursed when rendered by clinical diagnostic laboratories.
Effective for dates of service on or after March 13, 2020, the American Medical Association (AMA) created
a new CPT (Current Procedural Terminology) code, 87635, that will streamline coronavirus testing offered
by hospitals, health systems and laboratories in the United States. It is intended as industry standard for
reporting of novel coronavirus tests across the nation’s health care system.
Effective for dates of services on or after April 10, 2020, the American Medical Association (AMA) created
new CPT (Current Procedural Terminology) codes, 86328 and 86769, for serologic laboratory testing to
address the urgent clinical need to report antibody testing related to COVID-19.
Effective for dates of service on or after April 14, 2020, the Centers for Medicare and Medicaid Services
(CMS) has also established Healthcare Common Procedure Coding System (HCPCS) billing codes, U0003
and U0004 to represent clinical diagnostic laboratory tests that make use of high-throughput technologies.
This technology involves high sophisticated equipment that requires more intensive technician training and
more time intensive processes to ensure quality. High throughput technology uses a platform that employs
automated processing that allows for increased test capacity (i.e. more than two hundred specimens a day)
and allows for more rapid diagnosis.
Effective for dates of service on or after May 20, 2020, the American Medical Association (AMA) created
new CPT (Current Procedural Terminology) codes, 0202U for testing related to COVID-19.
Effective for dates of service on or after June 25, 2020, the American Medical Association (AMA) created
new CPT (Current Procedural Terminology) codes, 87426, 0223U and 0224U for testing related to
COVID19.
Effective for dates of service on or after August 10, 2020, the American Medical Association (AMA) created
new CPT (Current Procedural Terminology) codes 86408, 86409, 0225U and 0226U for testing related to
COVID-19.
Effective for dates of service on or after September 8, 2020, the American Medical Association (AMA)
created new CPT (Current Procedural Terminology) code 86413 for testing related to COVID-19.
PG0469 – 02/01/2021 Effective for dates of service on or after October 6, 2020, the American Medical Association (AMA) created
new CPT (Current Procedural Terminology) codes 87636, 87637, 87811, 0240U and 0241U for testing
related to COVID-19. As the COVID-19 pandemic continues to progress, and the season for influenza and
respiratory syncytial virus (RSV) approaches, clinicians need to be able to rapidly distinguish influenza A,
influenza B and RSV infections from infections caused by severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2).
Effective for dates of service on or after November 10, 2020, the American Medical Association (AMA)
created new CPT (Current Procedural Terminology) code 87428 for testing related to COVID-19.
Effective for dates of service on or after January 1, 2021, Centers for Medicare and Medicaid Services
(CMS) has developed Healthcare Common Procedure Coding System (HCPCS) billing code, U0005 to
represent testing by nucleic acid (DNR or RNA) using amplified probe technique and making use of high
throughput technologies that is completed within two calendar days from the date of specimen collection.
Code U0005 is reported in addition to code U0003 or U0004 when appropriate.
REVISION HISTORY EXPLANATION
ORIGINAL EFFECTIVE DATE: 03/17/2020
Date Explanation & Changes
Added the effective dates for the waived member responsibility for Covid-19 screening,
3/30/2020
when billed with U0001, U0002, or 87365, for the Elite and Commercial Product Lines
Added coverage determination that procedure 87635 is not covered for the Advantage
Product.
04/09/2020
Added diagnosis code Z11.59 and newly created diagnosis code U07.1
Added new codes G2023, G2024, 86328, 86769, U0003, and U0004
04/16/2020
Added codes G2023, G2024, 86328, 86769, U0003, and U0004 to the Advantage
04/29/2020
coverage, per ODM update.
Procedure 87635 removed from the Advantage product coverage. The Ohio Department of
Medicaid (ODM) has indicated that “87635 is the AMA code. Medicare recognizes U0001
04/30/2020 and U0002. All of these codes are used to report the same service. At this time, ODM
adopted the HCPCS U codes since rates were established. ODM will wait until 1/1/21 to
make any possible changes or allow both.”
Updated coverage - documenting Advantage coverage of 87635, ODM.
05/21/2020 Additionally, additional coverage for procedures U0002-QW and 87635-QW, effective date
3/20/2020, the acceptance of modifier QW is an expansion of coverage
Per ODM lab, testing 0202U is an expansion of coverage, Advantage Product only,
effective 05/20/2020.
06/01/2020
Extended cost share/co-pay waiver timeline: Expires the earlier of June 30, 2020 or the
expiration of the applicable state of emergency
06/08/2020 Procedure codes 0202U and C9803 approved for coverage for all product lines
Expiration date extended to July 31, 2020 or expiration of the applicable state of
emergency.
06/30/2020
Testing criteria documented.
Update COVID symptoms per the CDC guidance
Per CMS, new codes effective June 25, 2020; 87426, 0223U and 0224U, added to the
07/13/2020
medical policy, all product lines
Expiration date extended to August 31, 2020 or expiration of the applicable state of
0714/2020
emergency
Expiration date extended to September 30, 2020 or expiration of the applicable state of
08/07/2020
emergency.
PG0469 – 02/01/2021 Additionally, clarified the ordering requirements for testing to be: Screening/Testing must be
supported by a Physician Order or State Law, or meeting the Health Department Criteria
Screening, performed in an FDA approved facility/laboratory location, in accordance with
CDC guidelines [Per CMS MLN NN11815, Implementation Date: July 6, 2020; Revisions to
Ordering Requirement for Clinical Laboratory Diagnostic Testing-“In the interim final rule
with comment period, CMS-531-IFC, Medicare and Medicaid Programs, Basic Health
Program, and Exchanges; Additional Policy and Regulatory Revision in Response to
theCOVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for
the Skilled Nursing Facility Quality Reporting Program, on an interim basis for the duration
of the PHE for the COVID-19 pandemic, CMS removed the requirement that certain clinical
diagnostic laboratory tests must be ordered by a treating physician or non-physician
practitioner (NPP). This will allow any healthcare professional authorized to do so under
State law to order COVID-19 diagnostic laboratory tests (including serological and antibody
tests). Because the symptoms for coronavirus, influenza and respiratory syncytial virus
(RSV) are often the same, such that concurrent testing for all three viruses is warranted,
this interim policy also applies to influenza and RSV tests, but only when they are given in
conjunction with a medically necessary COVID-19 diagnostic laboratory test to establish or
rule out a COVID-19 diagnosis or identify an adaptive immune response to SARS-COV-2.
https://www.cms.gov/files/document/covid-medicre-and-medicaid-ifc2.pdf
Completed review related to testing coverage beyond signs/symptoms and exposure.
Testing for return to work, employment, education, participation in sports, admission to
educational/residential institutions, routine and/or physicals, court order or other third-party
08/24/2020
requirements is not covered. Testing for public health surveillance purposes is also not
covered.
Added noncovered Z diagnosis codes
Expiration date extended to December 31, 2020 or expiration of the applicable state of
09/15/2020
emergency
Added lab codes 86408, 86409, 0225U and 0226U which have an effective date of
09/20/2020
8/10/2020
Per ODM, added lab codes 87636, 87637, 87811, 0240U and 0241U which have an
10/28/2020 effective date of 10/6/2020, Advantage product line.
Updated policy documentation to industry standards
01/01/2021 Medical policy placed on the new Paramount Medical Policy Format
Clarified Limitations and Exclusions - Added ‘travel’ to the noncovered COVID testing, as
02/01/2021 travel falls under not meeting a medical indication
Updated policy documentation to industry standards
REFERENCES/RESOURCES
The Centers for Disease Control and Prevention (CDC) https://www.cdc.gov/coronavirus/2019-
ncov/hcp/clinical-criteria.html
Centers for Medicare and Medicaid Services, CMS Manual System and other CMS publications and
services
Ohio Department of Medicaid http://jfs.ohio.gov/
Centers for Medicare and Medicaid Services, Healthcare Common Procedure Coding System, HCPCS
Release and Code Sets
Industry Standard Review
PG0469 – 02/01/2021PG0469 – 02/01/2021
You can also read
