HIM.NC.CG.CP.MP.01 Infectious Disease: Respiratory Lab Testing
2024.1
Date of Last Revision: 04/24

Coding Implications
Revision log

INFECTIOUS DISEASE:

RESPIRATORY LAB TESTING

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

OVERVIEW

Respiratory illnesses cause significant morbidity and mortality within the United States and around the world. Seasonal influenza, respiratory syncytial virus (RSV), and SARS-CoV-2 infect many individuals each year, and while most will recover with no complications, a significant number will be hospitalized or die. Diagnostic testing for upper respiratory tract infections can be very useful for clinicians, as clinical signs and symptoms of these infections can have significant overlap between pathogens. Accurate and rapid testing techniques may aid clinicians, via identification of a specific pathogen, in selecting the best course of treatment for patients. Optimally, treatment is started within 48-72 hours of diagnosis. Testing methods range from culture and microscopy to immunoassays and advanced molecular diagnostic techniques; technology in this space is evolving rapidly and clinical guidelines can lag as a result.

This policy is intended for use in the outpatient setting.

POLICY REFERENCE TABLE

| | Biofire FilmArray Respiratory Panel 2.1 (Biofire Diagnostics) | |

| | QIAstat-Dx Respiratory SARS-CoV-2 Panel (QIAGEN Sciences) | |

| | ePlex Respiratory Pathogen Panel 2 (GenMark Diagnostics, Inc) | |

| | Respiratory Pathogen with ABR (RPX) (Lab Genomics LLC, Thermofisher Scientific) | |

| | Respiratory Virus PCR Panel IV (Quest Diagnostics) | |

| | Respiratory Viral Panel, PCR (Quest Diagnostics) | |

| SARS-CoV-2, RSV, or Influenza A/B, OR Multiplex Respiratory Viral Panels with 5 or Fewer Targets | Xpert Xpress SARS-CoV-2/Flu/RSV for SARS-CoV-2 and Flu targets only (Cepheid) | 3, 6, 7 |

| | Xpert Xpress SARS-CoV-2/Flu/RSV for all targets (Cepheid) | |

| | Infectious Agent Antigen Detection by Immunoassay | |

| | Infectious Agent Antigen Detection by Immunoassay, Qualitative or Semiquantitative | |

| | Infectious Agent Antigen Detection by Immunoassay, Qualitative or Semiquantitative, SARS-CoV-2 and Flu A/B | |

| | Influenza A and B and RSV RNA, Qualitative, Real-Time RT-PCR (Quest Diagnostics) | |

| | SARS-CoV-2 RNA (COVID-19), Qualitative NAAT (Quest Diagnostics) | |

| | SARS-CoV-2 RNA (COVID-19) and Influenza A and B, Qualitative NAAT (Quest Diagnostics) | |

| | Infectious Agent Antigen Detection by Nucleic Acid (DNA or RNA) SARS-CoV-2/Flu/RSV Multiplex Amplified Probe Technique | |

| | Infectious Agent Antigen Detection by Immunoassay with Direct Optical Observation | |

| Bacterial Respiratory Infection/Pneumonia Panels | Infectious Agent: Chlamydia pneumoniae Detection by Nucleic Acid (DNA or RNA), Direct Probe Technique | 3 |

| | Chlamydophila pneumoniae, DNA, Qualitative, Real-Time PCR (Quest Diagnostics) | |

| | Infectious Agent: Chlamydia pneumoniae Detection by Nucleic Acid (DNA or RNA), Quantification | |

| | Legionella DNA, Qualitative, Real-Time PCR (Quest Diagnostics) | |

| | Infectious Agent: Mycoplasma pneumoniae Detection by Nucleic Acid (DNA or RNA), Direct Probe Technique | |

| | Mycoplasma pneumoniae, DNA PCR (Labcorp) | |

| | Infectious Agent: Mycoplasma pneumonia Detection by Nucleic Acid (DNA or RNA), Quantification | |

| Influenza A and B Antibody Tests | Influenza Type A and Type B Antibody, Serum (Quest Diagnostics) | 1 |

SARS-CoV-2, RSV, or Influenza A/B, OR Multiplex Respiratory Viral Panels with 5 or Fewer Targets

I. SARS-CoV-2, RSV, or Influenza A/B, OR Multiplex Respiratory Viral Panels with 5 or fewer targets, may be considered medically necessary when:

A. The member/enrollee presents in the outpatient setting with signs or symptoms of an acute respiratory infection, AND

B. Results of the testing will influence the member’s/enrollee’s clinical management.

II. Current evidence does not support the use of SARS-CoV-2, RSV, or Influenza A/B, OR Multiplex Respiratory Viral Panels with 5 or fewer targets, for all other indications.

Bacterial Respiratory Infection/Pneumonia Panels

I. Bacterial Respiratory Infection/Pneumonia Panels may be considered medically necessary when:

A. The member/enrollee presents in the outpatient setting with signs or symptoms of an acute respiratory infection, AND

B. The member/enrollee meets any of the following criteria:

1. New or worsening lung infiltrates, OR

2. Moderate to severe upper respiratory illness, OR

3. Has received empiric antibiotics before obtaining cultures, OR

4. Has possible multidrug-resistant bacteria or polymicrobial infection, AND

C. Results of the testing will influence the member’s clinical management.

II. Current evidence does not support the use of Bacterial Respiratory Infection/Pneumonia Panels for all other indications.

Influenza A and B Antibody Tests

I. Current evidence does not support the use of Influenza A and B Antibody Tests for the purpose of diagnosing influenza.

NOTES AND DEFINITIONS

1. Moderate to severe upper respiratory illness includes one or more clinical findings of lower respiratory illness (e.g., pneumonia, severe cough/bronchitis, shortness of breath, difficulty breathing).

2. Severe pneumonia is defined by the Infectious Diseases Society of America/American Thoracic Society Criteria as: the presence of one major criterion or at least three minor criteria.

Minor criteria: respiratory rate ≥30 breaths/min, PaO2/FiO2 ratio ≤250, multilobar infiltrates, confusion/disorientation, uremia (blood urea nitrogen level ≥20 mg/dl), leukopenia (white blood cell count <4,000 cells/µl), thrombocytopenia (platelet count <100,000/µl), hypothermia (core temperature <36°C), and hypotension requiring aggressive fluid resuscitation.

Major criteria: septic shock with need for vasopressors and respiratory failure requiring mechanical ventilation.

3. Airway disease is a nonspecific clinical term for a heterogeneous group of conditions including chronic obstructive pulmonary disease (COPD), emphysema, cystic fibrosis, asthma, and bronchiectasis.

4. Signs and symptoms of acute respiratory infection include upper or lower respiratory tract symptoms (cough, runny nose, sore throat, bronchitis, pneumonia, bronchiolitis), with or without fever, influenza-like illness (ILI) (fever and either cough or sore throat), and respiratory distress (difficulty in breathing; often characterized by increased respiratory rate and use of accessory muscles of breathing).

BACKGROUND AND RATIONALE

Syndromic/Multiplex Respiratory Panels with 6 or More Targets

Infectious Diseases Society of America

The IDSA published clinical and diagnostic recommendations in 2020 regarding molecular testing for acute respiratory tract infections (RTIs). These recommendations state the following:

“Multiplex viral NAAT [nucleic acid amplification tests] (potentially combined with bacterial NAAT) also make clinical sense for immunocompromised and critically ill patients with pneumonia as well as for those with exacerbations of airway disease.” (p. 2748).

SARS-CoV-2, RSV, or Influenza A/B, OR Multiplex Respiratory Viral Panels with 5 or Fewer Targets

Infectious Diseases Society of America

The IDSA published clinical and diagnostic recommendations in 2020 regarding molecular testing for acute respiratory tract infections (RTIs). These recommendations state the following:

“Molecular testing for multiple respiratory viruses simultaneously may also be more cost-effective than traditional antigen- or culture-based methods from a laboratory perspective, especially given certain thresholds of disease prevalence.” (p. 2744)

Centers for Disease Control and Prevention

The CDC states the following on their website discussing RSV: “Healthcare providers should consider RSV in patients with respiratory illness, particularly during the RSV season.”

The CDC states the following on their website discussing COVID-19: “Key times to get tested: if you have symptoms, test immediately.”

Bacterial Respiratory Infection/Pneumonia Panels

Infectious Diseases Society of America

The IDSA published clinical and diagnostic recommendations in 2020 regarding molecular testing for acute respiratory tract infections (RTIs). These recommendations state the following:

“…bacterial NAAT may prove most useful in situations where patients have new or worsening lung infiltrates, are moderately to severely ill, have received empiric antibiotics before obtaining cultures, and/or there is concern for multidrug-resistant bacteria or a polymicrobial infection.” (p. 2747)

Influenza A and B Antibody Tests

Infectious Diseases Society of America

The IDSA published clinical practice guidelines in 2018 which addressed testing criteria for seasonal influenza A and B viruses. These guidelines state that serologic testing for the diagnosis of influenza should not be used by clinicians, because the results from a single serum specimen cannot be reliably interpreted. (p. 898)

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 reimbursement of covered services.

HIM.NC.CG.CP.MP.01 Infectious Disease: Respiratory Lab Testing 2024.1 Date of Last Revision: 04/24

ambetter of North Carolina Inc.

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HIM.NC.CG.CP.MP.01 Infectious Disease: Respiratory Lab Testing 2024.1 Date of Last Revision: 04/24

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HIM.NC.CG.CP.MP.01 Infectious Disease: Respiratory Lab Testing 2024.1 Date of Last Revision: 04/24

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HIM.NC.CG.CP.MP.01 Infectious Disease: Respiratory Lab Testing 2024.1 Date of Last Revision: 04/24

ambetter of North Carolina Inc.

6. RSV. Center for Disease Control and Prevention. Published 2019. https://www.cdc.gov/rsv/clinical/index.html. Accessed January 4, 2024.
7. CDC. COVID-19 and Your Health. Centers for Disease Control and Prevention. Published February 11, 2020. https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html#when-to-get-tested. Accessed January 4, 2024.

Important Reminder

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HIM.NC.CG.CP.MP.01 Infectious Disease: Respiratory Lab Testing 2024.1 Date of Last Revision: 04/24

ambetter of North Carolina Inc.

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 is 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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HIM.NC.CG.CP.MP.01 Infectious Disease: Respiratory Lab Testing 2024.1 Date of Last Revision: 04/24

ambetter of North Carolina Inc.

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