Respiratory Pathogen Panel Testing

LCD Information Document Information Source LCD ID N/A LCD ID L38916 Original ICD-9 LCD ID Not Applicable LCD Title Respiratory Pathogen Panel Testing Proposed LCD in Comment Period N/A Source Proposed LCD DL38916 Opens in a new window Original Effective Date For services performed on or after 07/11/2021 Revision Effective Date N/A Revision Ending Date N/A Retirement Date N/A Notice Period Start Date 05/27/2021 Notice Period End Date 07/10/2021 CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. CPT is a registered trademark of the American Medical Association. 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Issue Issue Description Issue - Explanation of Change Between Proposed LCD and Final LCD CMS National Coverage Policy This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for respiratory pathogen panel testing. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for respiratory pathogen panel testing and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site: IOM Citations: CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD Social Security Act (Title XVIII) Standard References: Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury. Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations. Code of Federal Regulations (CFR) References: CFR, Title 42, Volume 2, Chapter IV, Part 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions CFR, Title 42, Volume 2, Chapter IV, Part 411.15(a), Particular services excluded from coverage CFR, Title 42, Volume 2, Chapter IV, Part 493, Laboratory Requirements Coverage Indications, Limitations, and/or Medical Necessity Compliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits. History/Background and/or General Information Diagnostic testing for identification of pathogens that are causative for respiratory infections has evolved over the years. The aim is for rapid, accurate, and sensitive identification in an effort to improve patient outcomes through improved clinical decision making. These new technologies include nucleic acid-based amplification techniques. The focus of this LCD is respiratory pathogen panel testing, which typically includes detection for multiple virus pathogens by amplification of target DNA and is currently the most popular technique that can provide rapid, accurate, and sensitive results.1 Even with the widespread use of respiratory pathogen panel testing, only a few methods are available that not only detect respiratory pathogens but are also U.S. Food and Drug Administration (FDA) approved. Please see the FDA link for approved/cleared respiratory pathogen panel tests. https://www.fda.gov/. 2 It is recognized that labs may not have FDA approval/clearance of their products, i.e., laboratory developed tests (LDTs). At the time of this publication, tests are not limited to FDA approved/cleared products only. Coverage for tests is based on demonstration of analytical and clinical validity and clinical utility at a level that meets the Medicare medically reasonable and necessary requirement. Covered Indications Respiratory pathogen panel testing in the outpatient setting by a Part B provider (e.g., physician's office, independent clinical laboratory) will be considered medically reasonable and necessary when all of the following are met: Panels with ≤5 respiratory pathogens are performed, and BOTH of the following criteria are met: The outpatient setting is equipped to deliver timely reporting of results to providers AND, For patients where the test result aids clinical management with the goal of an improved health outcome for the patient. Limitations The following is considered not medically reasonable and necessary: Panels with >5 respiratory pathogens performed in the Part B outpatient setting.3 Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules. Summary of Evidence “For outpatient adults with acute cough and suspected pneumonia, we suggest that there is no need for routine microbiological testing (Ungraded Consensus-based statement)Remarks: Microbiologic testing should be considered if the results may result in a change of therapy.”8 The IDSA's 2018 evidence-based clinical practice guideline for seasonal influenza9 notes that timely diagnosis of influenza may increase the appropriate use of antivirals and decrease the inappropriate use of antibiotics. The grading of evidence is based on the U.S. Public Health Service Grading System for ranking recommendations in clinical guidelines. The recommendations for outpatient testing and panel testing include the following statements: “Clinicians should use rapid molecular assays (i.e., nucleic acid amplification tests) over rapid influenza diagnostic tests (RIDTs) in outpatients to improve detection of influenza virus infection (A-II).” “Clinicians should use multiplex RT-PCR assays targeting a panel of respiratory pathogens, including influenza viruses, in hospitalized immunocompromised patients (A-III).” “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) (B-III).”9 Consensus Statements Ramirez et al’s 2020 Treatment of Community-Acquired Pneumonia in Immunocompromised Adults10 is a consensus document addressing initial treatment of the immunocompromised patient who presents to the hospital with community acquired pneumonia. It is noted that the number of immunocompromised people at risk for CAP is increasing and is estimated to be 3% of the U.S. population. The document includes a table (Table 2)10 that identifies patient conditions qualifying patients as immunocompromised, which is listed below. Primary immune deficiency diseases Active malignancy or malignancy within 1 yr of CAP, excluding patients with localized skin cancers or early-stage cancers (e.g., stage 1 lung cancer) Receiving cancer chemotherapy HIV infection with a CD4 T-lymphocyte count <200 cells/µL or percentage,14% Solid organ transplant Hematopoietic stem cell transplantation Receiving corticosteroid therapy with a dose ≥20mg prednisone or equivalent daily for ≥14d or a cumulative dose >700mg of prednisone Receiving biological immune modulators Receiving disease-modifying antirheumatic drug or other immunosuppressive drugs (e.g., cyclosporin, cyclophosphamide, hydroxychloroquine, methotrexate) They note patients with common comorbid conditions such as diabetes, chronic lung disease, liver disease, kidney disease and the elderly and frail are relatively immunocompromised; however, these patients are typically infected with the same spectrum of organisms that cause CAP in younger or healthier adults, with their treatments covered in the current guidelines. For the immunocompromised, as defined in this article, they recommend a low threshold for hospitalization, with the suggestion of a comprehensive microbiological workup with the goal to perform pathogen-directed therapy and de-escalation of therapy. The microbiologic workup should be individualized and includes a table with specific immune deficiencies and associated respiratory pathogens. Additionally, a negative nasopharyngeal PCR result does not rule out a viral pneumonia, and with high suspicion the PCR should be done on bronchoscopy samples. Furthermore, finding a virus by PCR does not rule out a bacterial infection. The document does not address outpatient microbiological studies. Contractor Advisory Committee (CAC) Advisory Panel Meeting General consensus from the CAC panel is that there is accuracy and reliability in these respiratory pathogen panels and that the results of this testing may improve patient health outcomes. The CAC panel also noted that there is a gap in the literature when it comes to patient health outcomes related to the results and how it affects patient treatment and/or management especially with pathogens of lower prevalence that some of the respiratory pathogen panels include. Analysis of Evidence (Rationale for Determination)

Compliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits. History/Background and/or General Information Diagnostic testing for identification of pathogens that are causative for respiratory infections has evolved over the years. The aim is for rapid, accurate, and sensitive identification in an effort to improve patient outcomes through improved clinical decision making. These new technologies include nucleic acid-based amplification techniques. The focus of this LCD is respiratory pathogen panel testing, which typically includes detection for multiple virus pathogens by amplification of target DNA and is currently the most popular technique that can provide rapid, accurate, and sensitive results. 1 Even with the widespread use of respiratory pathogen panel testing, only a few methods are available that not only detect respiratory pathogens but are also U.S. Food and Drug Administration (FDA) approved. Please see the FDA link for approved/cleared respiratory pathogen panel tests. https://www.fda.gov/. 2 It is recognized that labs may not have FDA approval/clearance of their products, i.e., laboratory developed tests (LDTs). At the time of this publication, tests are not limited to FDA approved/cleared products only. Coverage for tests is based on demonstration of analytical and clinical validity and clinical utility at a level that meets the Medicare medically reasonable and necessary requirement. Covered Indications Respiratory pathogen panel testing in the outpatient setting by a Part B provider (e.g., physician's office, independent clinical laboratory) will be considered medically reasonable and necessary when all of the following are met: Panels with ≤5 respiratory pathogens are performed, and BOTH of the following criteria are met: The outpatient setting is equipped to deliver timely reporting of results to providers AND , For patients where the test result aids clinical management with the goal of an improved health outcome for the patient. Limitations The following is considered not medically reasonable and necessary: Panels with >5 respiratory pathogens performed in the Part B outpatient setting. 3 Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.