Molecular Respiratory Infection Pathogen Panel (RIPP) Testing
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Lab Management Guidelines V1.0.2021
Molecular Respiratory Infection
Pathogen Panel (RIPP) Testing
MOL.CS.293.I
v1.0.2021
Introduction
Molecular respiratory infection testing is addressed by this guideline.
Procedures addressed
The inclusion of any procedure code in this table does not imply that the code is under
management or requires prior authorization. Refer to the specific Health Plan's
procedure code list for management requirements.
Procedure(s) addressed by this Procedure code(s)
guideline
BioFire FilmArray Respiratory Panel (RP) 0098U
EZ
BioFire FilmArray Respiratory Panel (RP) 0099U
BioFire FilmArray Respiratory Panel 2 0100U
(RP2)
BioFire Respiratory Panel 2.1 including 0202U
SARS-CoV-2
BioFire FilmArray Pneumonia Panel 0151U
ePlex Respiratory Pathogen (RP) Panel 0115U
ePlex Respiratory Pathogen Panel 2 0225U
Infectious agent detection by nucleic acid 87636
(DNA or RNA); severe acute respiratory
syndrome coronavirus 2 (SARSCoV-2)
(Coronavirus disease [COVID-19]) and
influenza virus types A and B, multiplex
amplified probe technique
Infectious agent detection by nucleic acid 87637
(DNA or RNA); severe acute respiratory
syndrome coronavirus 2 (SARSCoV-2)
(Coronavirus disease [COVID-19]),
influenza virus types A and B, and
respiratory syncytial virus, multiplex
amplified probe technique
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Procedure(s) addressed by this Procedure code(s)
guideline
Infectious agent detection by nucleic acid 87631
(DNA or RNA); respiratory virus (eg,
adenovirus, influenza virus, coronavirus,
metapneumovirus, parainfluenza virus,
respiratory syncytial virus, rhinovirus),
includes multiplex reverse transcription,
when performed, and multiplex amplified
probe technique, multiple types or
subtypes, 3-5 targets
Infectious agent detection by nucleic acid 87632
(DNA or RNA); respiratory virus (eg,
adenovirus, influenza virus, coronavirus,
metapneumovirus, parainfluenza virus,
respiratory syncytial virus, rhinovirus),
includes multiplex reverse transcription,
when performed, and multiplex amplified
probe technique, multiple types or
subtypes, 6-11 targets
Infectious agent detection by nucleic acid 87633
(DNA or RNA); respiratory virus (eg,
adenovirus, influenza virus, coronavirus,
metapneumovirus, parainfluenza virus,
respiratory syncytial virus, rhinovirus),
includes multiplex reverse transcription,
when performed, and multiplex amplified
probe technique, multiple types or
subtypes, 12-25 targets
QIAstat-Dx Respiratory SARS CoV-2 0223U
Panel
Xpert Xpress SARSCoV-2/Flu/RSV 0240U
(SARSCoV-2 & Flu targets only)
Xpert Xpress SARSCoV-2/Flu/RSV (all 0241U
RIPP
targets)
What is Respiratory Pathogens Panel Testing
Definition
Respiratory pathogens panel testing is the use of molecular technologies to detect
respiratory pathogens directly in a clinical sample.
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In spite of the continued utilization of conventional diagnostic methods in clinical
microbiology laboratories, the expanded availability of molecular methods for
detection of pathogens directly in clinical specimens is changing the paradigm for
diagnosis and management of patients with infectious diseases. One of the recent
reasons for these changes has been the development of syndromic-based multiplex
molecular panels, in this case, for respiratory presentations, with the ability to
simultaneously detect, differentiate, and even subtype viral/bacterial pathogens in
patient specimens.1
Viral pathogens are the most common cause of respiratory tract infections.
Seasonal influenza contributes to substantial morbidity and mortality each year in
the United States. However, in a large portion of patients with respiratory tract
infections, other viruses and non-cultivable organisms have been found to cause
substantial morbidity and mortality.
The ability to detect a large number pathogens rapidly and with high sensitivity and
specificity has the potential to transform clinical microbiology as a continuing critical
component of laboratory medicine. However, it is important to consider whether
these tests should be front-line tests used for all patients with acute respiratory
illness or whether their use should be limited to specific patients.
Test Information
Introduction
This section of the guideline contains information about testing for respiratory
pathogens.
Respiratory panels may provide sample-to-answer results, using integrated nucleic
acid extraction, amplification and detection with testing times of as little as 1 hour,
typically using nasopharyngeal swab specimens. Several test systems have
received FDA-clearance for the detection of respiratory tract pathogens, which has
facilitated their rapid integration into routine testing. Other test platforms may
include laboratory-validated panels that are customized for clinicians at their service
clinical practice networks.
The menu of analytes on several panels is for the first time providing access to RIPP
routine testing for pathogens that have previously been difficult to detect, or for
which testing was only available at reference laboratories (i.e. norovirus,
coronaviruses, Chlamydophila pneumoniae, Mycoplasma pneumoniae). These
assays detect 12-20 pathogens and some include pathogens that typically cause
different manifestations of infection, although they infect the same organ system.
Analytically, the molecular assays usually exhibit comparative or superior detection
rates compared to conventional methods which also result in an increased rate of
diagnosis for affected patients.2,3 In addition, multiplex polymerase chain reaction
(mPCR) molecular panels allow laboratories to consolidate testing for a broad
range of pathogens from the same samples. This consolidation provides
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opportunities to eliminate conventional testing methodologies, including direct
fluorescent antibody (DFA) and cell culture for the detection of respiratory viruses.
However, the fixed nature of the mPCR panels raises the concern that they might
include pathogens causing infections with sufficiently clinical/epidemiological
diversity, such that, in turn, simultaneous testing for those pathogens should be
rare. Alternatively, the differences might be detectable by rapid, accurate and
inexpensive tests (e.g. the Gram stain) that are part of routine testing. 4 It is
reasonable to assert that negative test results for common pathogens should
typically precede testing for uncommon pathogens.
Guidelines and Evidence
Introduction
The following section includes relevant guidelines and evidence pertaining to
respiratory pathogens panel testing.
American Society of Transplantation/Canadian Society of Transplantation
Manuel (2013) was modified from a previous guideline published in the American
Journal of Transplantation in 2009; 9(Suppl 4): S166–S172, and endorsed by American
Society of Transplantation/Canadian Society of Transplantation. 5 Guidelines were
again updated in 2019 by the American Society of Transplantation Infectious Diseases
Community of Practice:6
“Since one cannot clinically distinguish disease caused by any of the respiratory
viruses, diagnosis using broad ranging techniques should be considered
particularly in the early period after transplantation or augmented
immunosuppression and during respiratory viral season, particularly among lung
transplant recipients.”
“Nucleic acid amplification assay appear to be the most sensitive…and allow for
simultaneous detection of a broad range of respiratory pathogens from a single
sample and are therefore the preferred diagnostic testing method for
immunocompromised patients. Multiplex PCR assays provide the advantage of
identification of viruses not routinely found by conventional methods...” RIPP
Infectious Disease Society of America (IDSA)
In the 2018 IDSA practice guidelines for the “Diagnosis, Treatment, Chemoprophylaxis,
and Institutional Outbreak Management of Seasonal Influenza,” recommendations for
diagnostic testing include:7
“Clinicians should use multiplex RT-PCR assays targeting a panel of respiratory
pathogens, including influenza viruses, in hospitalized immunocompromosed
patients (A-III).”
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“Clinicians can consider using multiplex RT-PCR assays targeting a panel of
respiratory pathogens, including influenza viruses, in hospitalized patients who are
not immunocompromised if it might influence care (eg, aid in cohorting decisions,
reduce testing, or decrease antibiotic use) (B-III).”
British Committee for Standards in Hematology
A joint working group established by the Hemato-oncology subgroup of the British
Committee for Standards in Hematology, the British Society for Bone Marrow
Transplantation and the UK Clinical Virology Network has reviewed the available
literature and made recommendations in 2016 for the diagnosis and management of
respiratory viral infections in patients with hematological malignancies or those
undergoing hematopoietic stem cell transplantation. To illustrate: 8
“It is currently recommended that the diagnosis of respiratory viral infections is
made by quantitative nucleic acid amplification tests (NAATs), generically referred
to hereafter as PCR; clinicians should be able to liaise with their virology laboratory
colleagues regarding the interpretation of PCR results … A panel of viruses should
be included for PCR testing, including parainfluenza type 4.”
German Society for Haematology and Medical Oncology
A panel of 18 clinicians from the Infectious Diseases Working Party of the German
Society for Haematology and Medical Oncology convened to assess the available
literature and provide 2016 recommendations on the management of community
acquired respiratory virus infections including influenza, respiratory syncytial virus
(RSV), parainfluenza virus (PIV), human metapneumovirus (hMPV) and
adenovirus. Two relevant excerpts include:9
“Most data on this topic originate from patients following allogeneic stem cell
transplantation (allo-SCT), and we know little about community-acquired respiratory
virus (CARV) infections in cancer patients outside the setting of allo-SCT. However,
in recent years increasing evidence has been gathered about other cancer patients,
revealing clinical relevance of CARV infections in non-transplant patients.
Therefore, this guideline discusses CARV infections in all cancer patients with
ongoing relevant immunosuppression. It is left to the treating physician to assess
the degree and relevance of immunosuppression in the individual patient.” RIPP
“In the era of multiplex-test kits, it is difficult to make a definite recommendation with
regard to which viruses should be looked for. In the absence of any reliable data
regarding this question, the panel feels that it is wise to search for influenza, RSV,
PIV and viruses currently prevalent in the local environment in all
immunosuppressed cancer patients presenting with symptoms. Patients with more
severe disease (for example pneumonia or critical illness) may have the panel
broadened to include hMPV and adenovirus and even viruses that only rarely cause
lower respiratory tract infections like rhinovirus and coronavirus. However, evidence
for this approach is low and it is strongly advisable to define local guidelines on this
topic.”
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Fourth European Conference on Infections in Leukemia
A working group of the Fourth European Conference on Infections in Leukemia (ECIL-
4) 2011 reviewed the literature on community-acquired respiratory virus (CARV),
graded the available quality of evidence, and made the relevant diagnostic
recommendations according to the Infectious Diseases Society of America (IDSA)
grading system:10
First-line diagnostic testing should be performed for influenza A and B, RSV, and
human parainfluenza viruses (HPIV) (IDSA Grade A II).
Testing for other CARVs should be considered according to risk of exposure and
the local epidemiology, or if testing for the firstline CARVs is negative (IDSA Grade
B III).
Expert Written and Peer Reviewed Articles
There have been additionally referenced indications for the use of (typically viral)
respiratory pathogen panels, such as for adult patients appearing acutely ill, who are
potential hospital admissions, where, for example, such panel testing would be ordered
in the emergency department (ED). To illustrate, two randomized controlled studies
have described some possible favorable outcomes in the ED:
Brendish (2017)11 where respiratory viral panel testing did not ... “reduce the
proportion of patients treated with antibiotics. However, the primary outcome
measure failed to capture differences in antibiotic use because many patients were
started on antibiotics before the results of point-of-care testing (POCT) could be
made available. Although POCT was not associated with a reduction in the duration
of antibiotics overall, more patients in the POCT group received single doses or
brief courses of antibiotics than did patients in the control group. POCT was also
associated with a reduced length of stay and improved influenza detection and
antiviral use, and appeared to be safe.”
Brittain-Long (2011)2 found that ... “In the group of patients randomised for a rapid
result, 4.5% (9 of 202) of patients received antibiotics at the initial visit, compared to
12.3% (25 of 204) (P = 0.005) of patients in the delayed result group. At follow-up,
there was no significant difference between the groups: 13.9% (28 of 202) in the
rapid result group and 17.2% (35 of 204) in the delayed result group (P = 0.359), RIPP
respectively.” … with the conclusion that …“Access to a rapid method for etiologic
diagnosis of acute respiratory tract infections (ARTIs) may reduce antibiotic
prescription rates at the initial visit in an outpatient setting. To sustain this effect,
however, it seems necessary to better define how to follow and manage the patient
according to the result of the test, which warrants further investigation.”
Furthermore, critically-ill adult patients, particularly intensive care unit (ICU) patients,
lack the same evidentiary level for metrics such as the reduction of unnecessary
antibiotic use, which is a major cause of morbidity in hospitalized patients. However,
case series studies make a convincing case that respiratory viral pathogens are of
considerable relevance in the ICU setting. To illustrate, Choi (2012) 12 found that viral
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infection is common in adult patients with severe pneumonia. About one-third of
patients with severe community-acquired pneumonia or healthcare-associated
pneumonia had viral infections, and the mortality from viral infection and bacterial
infection was comparable. The viral agents involved in descending order of prevalence
were rhinovirus, parainfluenza virus (Types 3, 1, 2, and 4, respectively), hMPV,
influenza, RSV, and, more infrequently, cytomegalovirus, human coronavirus,
adenovirus, and enterovirus. Furthermore, Voiriot (2016) 13 observed a relatively more
complicated course among ICU patients with mixed bacterial and viral respiratory
infections.
Outcome data for use of multiplex panels in adult ambulatory patients is generally more
mixed. For example, Green et al. (2016) showed that use of a multiplex panel (Biofire
FilmArray v1.7 respiratory panel) in outpatient adults (VA patients) led to increased
rates of oseltamivir and decreased rates of antibiotics for patients diagnoses with
influenza, but there was no significant difference in antibiotic prescription rates
between patients who tested negative and those who had a non-influenza virus—
suggesting a targeted influenza diagnostic may have been adequate in their
population.14 When specifically evaluating patients at an ambulatory cancer center,
however, Krantz et al. (2019) found that multiplex viral testing on day 0 decreased the
risk of antibiotic prescriptions by half compared to patients who were not tested on day
0.15
It should be noted that the utility of multiplex testing for each institution and patient
population should be interpreted in the context of the turn-around-time (TAT) of the
assay(s) available. Wabe et al (2019) evaluated outcomes of patients presenting to the
emergency department before and after a transition from a standard multiplex PCR
performed at a centralized laboratory (TAT of 26.7 hours; 16 viruses) to a rapid
hospital-based assay that only detects influenza A, influenza B, and RSV (TAT 2.4
hours).16 A small, but statistically significant, decrease in hospital admissions was
noted after implementing the more limited, but rapid assay
Finally, however, there were no substantive peer-reviewed full articles which addressed
the relative clinical impact of ordering respiratory pathogen panels, with differing
numbers of infectious targets.
Criteria
RIPP
Introduction
Requests for molecular respiratory infection pathogen panel (RIPP) testing using
procedure codes are reviewed using the following clinical criteria.
87631, 87632, and 87633
The presence of acute respiratory symptoms in members 17 years of age or younger,
OR
The presence of acute respiratory symptoms in members of any age who are:
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Immunocompromised (as defined by ICD-10 codes), OR
Immunocompetent and receiving care for their acute respiratory symptoms in a
hospital setting as evidenced by the following
o Place of service code on the claim is: 19, 22, or 23 , or
o Bill type code on the claim is: 13X or 14X, OR
The following is a contraindication to RIPP testing in members 18 years of age or older:
Presence of respiratory symptoms that suggest a specific respiratory pathogen in
an immunocompetent adult.
Molecular RIPP testing is limited to the minimum number of targets needed for
therapeutic decision making. When ordering any configuration of infectious disease
targets, whether using RIPP or conventional testing, the medical record should clearly
indicate the differential diagnosis of possible microorganisms based upon member
history and presenting signs/symptoms.
It is not necessary to repeat a respiratory pathogen panel to ensure a causative
organism is cleared. If test of cure is indicated for a particular organism, individual
organism testing should be used. Therefore, repeat testing of any panel within a two
week time frame will not be reimbursed.
0098U, 0099U, 0100U, 0115U, and 0151U
These procedure codes are considered investigational and/or experimental and,
therefore, not eligible for reimbursement.
Billing and reimbursement
No more than one respiratory virus panel should be necessary on a single date of
service. Therefore, only one unit of the same panel code will be reimbursable and
two different panel codes (e.g. 87631, 87632, 87633, 0202U, or 0223U) cannot be
billed on the same date of service.
More than one type of test for the same organism will not be reimbursable for the
same date of service (e.g., 87631 and 87634 may not be billed together).
A code representing only the minimum panel necessary to detect the necessary
RIPP
targets should be billed. If the laboratory’s testing platform consists solely of a panel
of multiple targets, yet only a subset of the organisms are considered medically
necessary based on the above criteria, the lab may request reimbursement for that
subset of organisms using a procedure code that does not represent all organisms
included on the panel (e.g., bill 87632 if only 8 targets are necessary even if 12 or
more targets were tested as part of a panel usually billed with 87633).
Note Inpatient services are beyond the scope and domain of this guideline.
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Although outbreak investigations may sometimes require use of RIPP testing, the
public health evaluations of such outbreaks are beyond the scope and domain of this
guideline.
ICD10 codes
ICD10 codes in this section may be used to support medical necessity as described in
the above criteria.
ICD10 Codes Indicating Cancer, Transplant, or Other Immunocompromise
ICD10 Code or Range Description
B20 Human immunodeficiency virus [HIV]
disease
B59 Pneumocystosis
C00.X-C96.X Malignant neoplasms
D37.X-D48.X Neoplasms of uncertain behavior,
polycythemia vera and myelodysplastic
syndromes
D60.X-D64.X Aplastic and other anemias and other
bone marrow failure syndromes
D70.X-D77 Other disorders of blood and blood-
forming organs
D80.X-D89.X Certain disorders involving the immune
mechanism
E40-E46 Malnutrition
I12.0 Hypertensive chronic kidney disease with
stage 5 chronic kidney disease or end
stage renal disease
I13.11 Hypertensive heart and chronic kidney
disease without heart failure, with stage 5
chronic kidney disease, or end stage renal
disease RIPP
I13.2 Hypertensive heart and chronic kidney
disease with heart failure and with stage 5
chronic kidney disease, or end stage renal
disease
K91.2 Postsurgical malabsorption, not elsewhere
classified
M35.9 Systemic involvement of connective
tissue, unspecified
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ICD10 Code or Range Description
N18.5 Chronic kidney disease, stage 5
N18.6 End stage renal disease
T86.X Complications of transplanted organs and
tissue
Z48.2X Encounter for aftercare following organ
transplant
Z49.X Encounter for care involving renal dialysis
Z94.X Transplanted organ and tissue status
Z99.2 Dependence on renal dialysis
References
Introduction
The following references are cited in the guideline.
1. American Society for Microbiology. Multiplex Array White Paper: Clinical Utility of
Multiplex Tests for Respiratory and Gastrointestinal Pathogens.
https://www.asm.org/index.php/statements-and-testimony/item/6691-wp-multiplex
Published July 18, 2017. Accessed July 18, 2017.
2. Brittain-Long R, Westin J, Olofsson S, Lindh M, Andersson LM. Access to a
polymerase chain reaction assay method targeting 13 respiratory viruses can
reduce antibiotics: a randomised, controlled trial. BMC Med. 2011;9:44.
3. Johansson N, Kalin M, Tiveljung-Lindell A, Giske CG, Hedlund J. Etiology of
community-acquired pneumonia: increased microbiological yield with new
diagnostic methods. Clin Infect Dis. 2010;50(2):202-209.
4. Schreckenberger PC, McAdam AJ. Point-Counterpoint: Large Multiplex PCR
Panels Should Be First-Line Tests for Detection of Respiratory and Intestinal
Pathogens. J Clin Microbiol. 2015;53(10):3110-3115.
RIPP
5. Manuel O, Estabrook M. RNA respiratory viruses in solid organ transplantation. Am
J Transplan. 2013;13 Suppl 4:212-219.
6. Manuel O, Estabrook M, American Society of Transplantation Infectious Diseases
Community of Practice. RNA respiratory viral infections in solid organ transplant
recipients: Guidelines from the American Society of Transplantation Infectious
Diseases Community of Practice. Clin Transplant. 2019;33(9):e13511.
7. Uyeki T, Bernstein H, Bradley J, et al. Clinical practice guidelines by the Infectious
Diseases Society of America: 2019 update on diagnosis, treatment,
chemoprophylaxis, and institutional outbreak management of seasonal influenza.
Clin Infect Dis. 2019;68(6):e1-e47.
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400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924 www.eviCore.comLab Management Guidelines V1.0.2021
8. Dignan FL, Clark A, Aitken C, et al. BCSH/BSBMT/UK clinical virology network
guideline: diagnosis and management of common respiratory viral infections in
patients undergoing treatment for haematological malignancies or stem cell
transplantation. Br J Haematol.2016;173(3):380-393.
9. von Lilienfeld-Toal M, Berger A, Christopeit M, et al. Community acquired
respiratory virus infections in cancer patients-Guideline on diagnosis and
management by the Infectious Diseases Working Party of the German Society for
haematology and Medical Oncology. Eur J Cancer (Oxford, England : 1990).
2016;67:200-212.
10. Hirsch HH, Martino R,Ward KN, Boeckh M, Einsele H, Ljungman P. Fourth
European Conference on Infections in Leukaemia (ECIL-4): guidelines for
diagnosis and treatment of human respiratory syncytial virus, parainfluenza virus,
metapneumovirus, rhinovirus, and coronavirus. Clin Infect Dis. 2013;56(2):258-
266.
11. Brendish NJ, Malachira AK, Armstrong L, et al. Routine molecular point-of-care
testing for respiratory viruses in adults presenting to hospital with acute respiratory
illness (ResPOC): a pragmatic, open-label, randomised controlled trial. Lancet.
2017;5(5):401-411.
12. Choi SH, Hong SB, Ko GB, et al. Viral infection in patients with severe pneumonia
requiring intensive care unit admission. Am J Respir Crit Care Med.
2012;186(4):325-332.
13. Voiriot G, Visseaux B, Cohen J, et al. Viral-bacterial coinfection affects the
presentation and alters the prognosis of severe community-acquired pneumonia.
Crit Care (London, England). 2016;20(1):375.
14. Green DA, Hitoaliaj L, Kotansky B, Campbell SM, Peaper DR. Clinical utility of on-
demand multiplex respiratory pathogen testing among adult outpatients. J Clin
Microbiol. 2016;54(12):2950-2955.
15. Krantz EM, Zier J, Stohs E, et al. Antibiotic prescribing and respiratory viral testing
for acute upper respiratory infections among adult patients at an ambulatory cancer
center. Clin Infect Dis Off Publ Infect Dis Soc Am. May 2019.
doi:10.1093/cid/ciz409 [Epup ahead of print].
16. Wabe N, Li L, Lindeman R, et al. The impact of rapid molecular diagnostic testing
for respiratory viruses on outcomes for emergency department patients. Med J RIPP
Aust. 2019;210(7):316-320.
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