Clinical Policy: Polymerase Chain Reaction Respiratory Viral Panel Testing

Reference Number: CP.MP.181
Date of Last Revision: 03/24
[Coding Implications](Coding Implications)
[Revision Log](Revision Log)

See [Important Reminder](Important Reminder) at the end of this policy for important regulatory and legal information.

Description

Medical necessity criteria for multiplex respiratory polymerase chain reaction (PCR) testing.

Note: For criteria applicable to Medicare plans, please see MC.CP.MP.181 Polymerase Chain Reaction Respiratory Viral Panel Testing.

Policy/Criteria

I. It is the policy of non-Medicare plans affiliated with Centene Corporation® that respiratory viral panels (RVPs) testing for five pathogens or fewer are considered medically necessary when meeting all of the following¹⁻⁸:
A. The member/enrollee has one of the following clinical indications for infectious disease testing:

1. The member/enrollee is immunocompetent, and the clinical indication includes a presumption of active infection or infection-associated complications that may include exacerbation of underlying disease) that require the identification of a causative organism for appropriate management. Note: Atypical clinical presentations of disease are considered appropriate indications for special populations who may not present with classic symptoms of infection (i.e., the elderly);

2. The member/enrollee is immunocompromised (i.e., those with weakened immune systems including those with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS), those who are taking immunosuppressive medications (i.e., chemotherapy, biologics, transplant-related immunosuppressive drugs, high-dose systemic corticosteroids and those with inherited diseases that affect the immune system (i.e., congenital immunoglobulin deficiencies). Note: atypical clinical presentations of disease are considered appropriate indications for testing. In this population, testing may be performed once as part of a pre-transplant evaluation, regardless of the presence of symptoms;
   B. The results of testing will impact clinical management in a manner already demonstrated in the peer-reviewed published literature to improve outcomes;
   C. Testing is performed according to the intended use of the test in the intended population for which the test was developed and validated;
   D. Targeted testing is not appropriate (i.e., will not provide sufficient information for the appropriate clinical management);
   E. The panel performed includes at least the minimum pathogens required for clinical decision making for its intended use that can be reasonably detected by the test;
   F. The registered test demonstrates equivalent or superior test performance characteristics - analytical validity (AV) and clinical validity (CV) - to established standard-of-care (SOC) methods (i.e., culture, pathogen-specific PCR) for the majority of targets included on the panel;

Clinical Policy

Polymerase chain reaction respiratory viral panel testing

II. It is the policy of Centene Corporation that RVPs testing for six pathogens or more are considered medically necessary when meeting the following:
A. The criteria in section I are met, and any of the following¹:

1. Performed in a healthcare setting that cares for critically ill individuals, such as the emergency department or inpatient hospital, and includes those in observation status;
2. Member/enrollee is immunocompromised, as defined in section I.A.2.;
3. Member/enrollee is immunocompetent and both of the following:
   a. A severe and established underlying respiratory pathology is present (i.e., severe asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, pulmonary fibrosis, radiation therapy to the lung);
   b. Treatment with antibiotics may be indicated according to established guidelines.¹⁸⁻¹⁹

Background

Polymerase chain reaction (PCR) respiratory viral panels (RVPs) may detect the RNA or DNA of multiple types of respiratory viruses as a single test, often through a nasal, nasopharyngeal, or oropharyngeal swab. Viral pathogens are the most common cause of respiratory tract infections.⁸ Rhinovirus, parainfluenza virus, coronavirus, adenovirus, respiratory syncytial virus (RSV), Coxsackie virus, human metapneumovirus, and influenza virus account for most cases of viral respiratory infections.¹⁰ Immunocompromised patients can develop severe lower respiratory tract infections from common respiratory viral pathogens that otherwise cause mild upper respiratory tract infections in healthy patients.¹¹

PCR testing is generally effective for confirming respiratory viral infections with very high sensitivity and specificity.⁸,¹² Respiratory viral infections often have nonspecific clinical presentations and, therefore, accurate and timely identification through PCR testing has the potential to optimize antiviral use when appropriate, decrease the spread of any viral infection, and to reduce the number of patients being treated with antibiotics unnecessarily.⁹,¹³⁻¹⁶ Multiplex PCR testing can detect a variety of respiratory viruses depending on the type and brand of testing being used.¹³ However, the diagnostic role and importance of these multi-pathogen panels in identifying specific viruses in the setting of a respiratory infection is quite limited because the care and management of the individual patient is rarely altered based upon the pathogen identified.¹⁷

Infectious Disease Society of America (IDSA)
The IDSA recommends that “clinicians should use multiplex RT-PCR assays targeting a panel of respiratory pathogens, including influenza viruses, in hospitalized immunocompromised patients.” Further, “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 (e.g., aid in cohorting decisions, reduce testing, or decrease antibiotic use).”²⁷⁽⁶⁹⁸⁾

Coding Implications

This clinical policy references Current Procedural Terminology (CPT®). CPT® is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2023, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for

Table 1: CPT codes that support medical necessity in any place of service, without diagnosis code requirements

Table 2: CPT codes that support medical necessity when billed with place of service codes in table 3, or a diagnosis code in both table 4 and table 5.

Table 3: Place of service codes supporting medical necessity for codes in table 2

Table 4: ICD-10 Diagnosis Codes that Support Medical Necessity for CPT Codes in Table 2 when Billed with a Diagnosis Code in Table 5

| B97.21 | SARS-associated coronavirus as the cause of diseases classified elsewhere |

| B97.29 | Other coronavirus as the cause of diseases classified elsewhere |

| J05.0 | Acute obstructive laryngitis [croup] |

| J06.9 | Acute upper respiratory infection, unspecified |

| J09.X1 | Influenza due to identified novel influenza A virus with pneumonia |

| J09.X2 | Influenza due to identified novel influenza A virus with other respiratory manifestations |

| J09.X3 | Influenza due to identified novel influenza A virus with gastrointestinal manifestations |

| J09.X9 | Influenza due to identified novel influenza A virus with other manifestations |

| J10.01 | Influenza due to other identified influenza virus with the same other identified influenza virus pneumonia |

| J10.08 | Influenza due to other identified influenza virus with other specified pneumonia |

| J10.1 | Influenza due to other identified influenza virus with other respiratory manifestations |

| J10.2 | Influenza due to other identified influenza virus with gastrointestinal manifestations |

| J10.81 | Influenza due to other identified influenza virus with encephalopathy |

| J10.82 | Influenza due to other identified influenza virus with myocarditis |

| J10.83 | Influenza due to other identified influenza virus with otitis media |

| J10.89 | Influenza due to other identified influenza virus with other manifestations |

| J11.08 | Influenza due to unidentified influenza virus with specified pneumonia |

| J11.1 | Influenza due to unidentified influenza virus with other respiratory manifestations |

| J11.2 | Influenza due to unidentified influenza virus with gastrointestinal manifestations |

| J11.81 | Influenza due to unidentified influenza virus with encephalopathy |

| J11.82 | Influenza due to unidentified influenza virus with myocarditis |

| J11.83 | Influenza due to unidentified influenza virus with otitis media |

| J11.89 | Influenza due to unidentified influenza virus with other manifestations |

| J12.0 | Adenoviral pneumonia |

| J12.1 | Respiratory syncytial virus pneumonia |

| J12.2 | Parainfluenza virus pneumonia |

| J12.3 | Human metapneumovirus pneumonia |

| J12.81 | Pneumonia due to SARS-associated coronavirus |

| J12.82 | Pneumonia due to coronavirus disease 2019 |

| J12.89 | Other viral pneumonia |

| J12.9 | Viral pneumonia, unspecified |

| J13 | Pneumonia due to Streptococcus pneumoniae |

| J15.0 | Pneumonia due to Klebsiella pneumoniae |

| J15.1 | Pneumonia due to Pseudomonas |

| J15.20 | Pneumonia due to staphylococcus, unspecified |

| J15.211 | Pneumonia due to Methicillin susceptible Staphylococcus aureus |

| J15.212 | Pneumonia due to Methicillin resistant Staphylococcus aureus |

| J15.29 | Pneumonia due to other staphylococcus |

| J15.3 | Pneumonia due to streptococcus, group B |

| J15.4 | Pneumonia due to other streptococci |

| J15.61 | Pneumonia due to Acinetobacter baumannii |

| J15.69 | Pneumonia due to other Gram-negative bacteria |

| J15.7 | Pneumonia due to Mycoplasma pneumoniae |

| J15.8 | Pneumonia due to other specified bacteria |

| J15.9 | Unspecified bacterial pneumonia |

| J16.0 | Chlamydial pneumonia |

| J16.8 | Pneumonia due to other specified infectious organisms |

| J18.0 | Bronchopneumonia, unspecified organism |

| J18.1 | Lobar pneumonia, unspecified organism |

| J18.2 | Hypostatic pneumonia, unspecified organism |

| J18.8 | Other pneumonia, unspecified organism |

| J18.9 | Pneumonia, unspecified organism |

| J20.0 | Acute bronchitis due to Mycoplasma pneumoniae |

| J20.1 | Acute bronchitis due to Hemophilus influenzae |

| J20.2 | Acute bronchitis due to streptococcus |

| J20.3 | Acute bronchitis due to coxsackievirus |

| J20.4 | Acute bronchitis due to parainfluenza virus |

| J20.5 | Acute bronchitis due to respiratory syncytial virus |

| J20.6 | Acute bronchitis due to rhinovirus |

| J20.8 | Acute bronchitis due to other specified organisms |

| J20.9 | Acute bronchitis, unspecified |

| J21.9 | Acute bronchiolitis, unspecified |

| J22 | Unspecified acute lower respiratory infection |

| J44.0 | Chronic obstructive pulmonary disease with (acute) lower respiratory infection |

| J44.1 | Chronic obstructive pulmonary disease with (acute) exacerbation |

| J45.31 | Mild persistent asthma with (acute) exacerbation |

| J45.32 | Mild persistent asthma with status asthmaticus |

| J45.41 | Moderate persistent asthma with (acute) exacerbation |

| J45.42 | Moderate persistent asthma with status asthmaticus |

| J45.51 | Severe persistent asthma with (acute) exacerbation |

| J45.52 | Severe persistent asthma with status asthmaticus |

| J45.901 | Unspecified asthma with (acute) exacerbation |

| J45.902 | Unspecified asthma with status asthmaticus |

| J84.116 | Cryptogenic organizing pneumonia |

| J84.117 | Desquamative interstitial pneumonia |

| J84.2 | Lymphoid interstitial pneumonia |

| J85.0 | Gangrene and necrosis of lung |

| J85.1 | Abscess of lung with pneumonia |

| J85.2 | Abscess of lung without pneumonia |

| J85.3 | Abscess of mediastinum |

| R05.1 | Acute cough |

| R05.2 | Subacute cough |

| R05.3 | Chronic cough |

| R05.8 | Other specified cough |

| R06.02 | Shortness of breath |

| R06.03 | Acute respiratory distress |

| R06.2 | Wheezing |

| R50.9 | Fever, unspecified |

| R65.20 | Severe sepsis without septic shock |

| R65.21 | Severe sepsis with septic shock |

| R78.81 | Bacteremia |

| T86.33 | Heart-lung transplant infection |

| T86.812 | Lung transplant infection |

| Z03.818 | Encounter for observation for suspected exposure to other biological agents ruled out |

| Z20.822 | Contact with and (suspected) exposure to COVID-19 |

| Z20.828 | Contact with and (suspected) exposure to other viral communicable diseases |

| U07.1 | COVID-19 |

Table 5: ICD-10 Codes that Support Medical Necessity for CPT codes in Table 2 when Billed with a Diagnosis Code in Table 4

| D64.89 | Other specified anemias |

| D70.0 | Congenital agranulocytosis |

| D70.1 | Agranulocytosis secondary to cancer chemotherapy |

| D70.2 | Other drug-induced agranulocytosis |

| D70.3 | Neutropenia due to infection |

| D70.4 | Cyclic neutropenia |

| D70.9 | Neutropenia, unspecified |

| D80.0 | Hereditary hypogammaglobulinemia |

| D80.1 | Nonfamilial hypogammaglobulinemia |

| D80.2 | Selective deficiency of immunoglobulin A [IgA] |

| D80.3 | Selective deficiency of immunoglobulin G [IgG] subclasses |

| D80.4 | Selective deficiency of immunoglobulin M [IgM] |

| D80.5 | Immunodeficiency with increased immunoglobulin M [IgM] |

| D80.6 | Antibody deficiency with near-normal immunoglobulins or with hyperimmunoglobulinemia |

| D80.8 | Other immunodeficiencies with predominantly antibody defects |

| D80.9 | Immunodeficiency with predominantly antibody defects, unspecified |

| D81.0 | Severe combined immunodeficiency [SCID] with reticular dysgenesis |

| D81.1 | Severe combined immunodeficiency [SCID] with low T- and B-cell numbers |

| D81.2 | Severe combined immunodeficiency [SCID] with low or normal B-cell numbers |

| D81.30 | Adenosine deaminase deficiency, unspecified |

| D81.31 | Severe combined immunodeficiency due to adenosine deaminase deficiency |

| D81.32 | Adenosine deaminase 2 deficiency |

| D81.39 | Other adenosine deaminase deficiency |

| D81.4 | Nezelof's syndrome |

| D81.5 | Purine nucleoside phosphorylase [PNP] deficiency |

| D81.6 | Major histocompatibility complex class I deficiency |

| D81.7 | Major histocompatibility complex class II deficiency |

| D81.810 | Biotinidase deficiency |

| D81.818 | Other biotin-dependent carboxylase deficiency |

| D81.82 | Activated Phosphoinositide 3-kinase Delta Syndrome [APDS] |

| D81.89 | Other combined immunodeficiencies |

| D81.9 | Combined immunodeficiency, unspecified |

| D82.0 | Wiskott-Aldrich syndrome |

| D82.1 | Di George's syndrome |

| D82.2 | Immunodeficiency with short-limbed stature |

| D82.3 | Immunodeficiency following hereditary defective response to Epstein-Barr virus |

| D82.4 | Hyperimmunoglobulin E [IgE] syndrome |

| D82.8 | Immunodeficiency associated with other specified major defects |

| D83.0 | Common variable immunodeficiency with predominant abnormalities of B-cell numbers and function |

| D83.1 | Common variable immunodeficiency with predominant immunoregulatory T-cell disorders |

| D83.2 | Common variable immunodeficiency with autoantibodies to B- or T-cells |

| D83.8 | Other common variable immunodeficiencies |

| D83.9 | Common variable immunodeficiency, unspecified |

| D84.0 | Lymphocyte function antigen-1 [LFA-1] defect |

| D84.1 | Defects in the complement system |

| D84.821 | Immunodeficiency due to drugs |

| D84.822 | Immunodeficiency due to external causes |

| D84.89 | Other immunodeficiencies |

| D84.9 | Immunodeficiency, unspecified |

| D89.0 | Polyclonal hypergammaglobulinemia |

| D89.1 | Cryoglobulinemia |

| D89.3 | Immune reconstitution syndrome |

| D89.41 | Monoclonal mast cell activation syndrome |

| D89.42 | Idiopathic mast cell activation syndrome |

| D89.43 | Secondary mast cell activation |

| D89.44 | Hereditary alpha tryptasemia |

| D89.49 | Other mast cell activation disorder |

| D89.810 | Acute graft-versus-host disease |

| D89.811 | Chronic graft-versus-host disease |

| D89.812 | Acute on chronic graft-versus-host disease |

| D89.813 | Graft-versus-host disease, unspecified |

| D89.82 | Autoimmune lymphoproliferative syndrome [ALPS] |

| D89.89 | Other specified disorders involving the immune mechanism, not elsewhere classified |

| E08.43 | Diabetes mellitus due to underlying condition with diabetic autonomic (poly)neuropathy |

| E10.43 | Type 1 diabetes mellitus with diabetic autonomic (poly)neuropathy |

| E11.43 | Type 2 diabetes mellitus with diabetic autonomic (poly)neuropathy |

| E13.43 | Other specified diabetes mellitus with diabetic autonomic (poly)neuropathy |

| E84.0 | Cystic fibrosis with pulmonary manifestations |

| J44.81 | Bronchiolitis obliterans and bronchiolitis obliterans syndrome |

| J44.89 | Other specified chronic obstructive pulmonary disease |

| J44.9 | Chronic obstructive pulmonary disease, unspecified |

| J45.991 | Cough variant asthma |

| J70.1 | Chronic and other pulmonary manifestations due to radiation |

| J84.01 | Alveolar proteinosis |

| J84.02 | Pulmonary alveolar microlithiasis |

| J84.03 | Idiopathic pulmonary hemosiderosis |

| J84.10 | Pulmonary fibrosis, unspecified |

| J84.112 | Idiopathic pulmonary fibrosis |

| J84.114 | Acute interstitial pneumonitis |

| J84.170 | Interstitial lung disease with progressive fibrotic phenotype in diseases classified elsewhere |

| J84.178 | Other interstitial pulmonary diseases with fibrosis in diseases classified elsewhere |

| J84.81 | Lymphangioleiomyomatosis |

| J84.82 | Adult pulmonary Langerhans cell histiocytosis |

| J84.89 | Other specified interstitial pulmonary diseases |

| O98.711 | Human immunodeficiency virus [HIV] disease complicating pregnancy, first trimester |

| O98.712 | Human immunodeficiency virus [HIV] disease complicating pregnancy, second trimester |

| O98.713 | Human immunodeficiency virus [HIV] disease complicating pregnancy, third trimester |

| T80.82XS | Complication of immune effector cellular therapy, sequela |

| Z51.11 | Encounter for antineoplastic chemotherapy |

| Z92.850 | Personal history of Chimeric Antigen Receptor T-cell therapy |

| Z92.858 | Personal history of other cellular therapy |

| Z92.86 | Personal history of gene therapy |

| Z94.0 | Kidney transplant status |

| Z94.1 | Heart transplant status |

| Z94.2 | Lung transplant status |

| Z94.3 | Heart and lungs transplant status |

| Z94.4 | Liver transplant status |

| Z94.5 | Skin transplant status |

| Z94.6 | Bone transplant status |

| Z94.81 | Bone marrow transplant status |

| Z94.82 | Intestine transplant status |

| Z94.83 | Pancreas transplant status |

| Z94.84 | Stem cells transplant status |

| Z94.89 | Other transplanted organ and tissue status |

Reviews, Revisions, and Approvals

CLINICAL POLICY

Polymerase chain reaction respiratory viral panel testing

Important Reminder

This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. “Health Plan” means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan’s affiliates, as applicable.

The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures.

This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time.

This clinical policy does not constitute medical advice, medical treatment or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care and are solely responsible for the medical advice and treatment of members/enrollees. This clinical policy is not intended to recommend treatment for members/enrollees. Members/enrollees should consult with their treating physician in connection with diagnosis and treatment decisions.

Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan.

This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members/enrollees and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members/enrollees and their representatives agree to be bound by such terms and conditions by providing services to members/enrollees and/or submitting claims for payment for such services.

Note: For Medicaid members/enrollees, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy.

Note: For Medicare members/enrollees, to ensure consistency with the Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs, LCDs, and Medicare Coverage Articles should be reviewed prior to applying the criteria set forth in this clinical policy. Refer to the CMS website at http://www.cms.gov for additional information.

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