May 2021 MOLDX NAAT/Pathogen Panel Testing

 https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?lcdid=38987&ver=11&contractorName=all&updatePeriod=938&sortBy=updated&bc=AAAABAAAAAAAAA

Proposed Local Coverage Determination (LCD):
MolDX: Multiplex Nucleic Acid Amplification Test (NAAT) Panels for Infectious Disease Testing (DL38988)

As released by MOLDX on May 20, 2021,for public comment.

Coverage Indications, Limitations, and/or Medical Necessity

This policy provides limited coverage for outpatient testing with panels using multiplex nucleic acid amplification techniques (NAATs) for infectious disease testing. This policy does NOT address coverage for the inpatient setting.

This policy defines a panel as a NAAT test that detects > 1 pathogen. This policy also differentiates (where appropriate) between small, targeted panels (up to 5 pathogens) and larger, expanded panels (≥6 pathogens). This distinction is primarily applied to the Respiratory and Gastrointestinal Panels.

This is NOT a coverage policy for metagenomic next-generation sequencing, mass spectrometry, fluorescence in situ hybridization (FISH), or testing using techniques other than multiplex polymerase chain reaction (PCR).

General Criteria For Coverage For A Multiplex NAAT Infectious Disease Test Panel

This Medicare Contractor will cover multiplex NAAT infectious disease panel tests when ALL of the following criteria are met:

• The patient has a clinical indication for infectious disease testing:
  • For immunocompetent patients, the clinical indication includes a presumption of active infection OR infection-associated complications (which may include exacerbation of underlying disease) that require the identification of a causative organism for appropriate management. 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).
  • For immunocompromised patients, atypical clinical presentations of disease are considered appropriate indications for testing. In this patient population, testing may be performed ONCE as part of a pre-transplant evaluation, regardless of the presence of symptoms.
  • Note: For certain panels, such as the Urogenital/Anogenital Panel, epidemiologic indication or potential exposure to pathogens as a result of a high-risk experience is considered a covered clinical indication, even in the absence of clinical symptoms. These are specifically noted below in LIMITED COVERAGE FOR EXPANDED (>5 Pathogens) PANEL TESTING.
• The results of testing will impact clinical management in a manner already demonstrated in the peer-reviewed published literature to improve patient outcomes.
• Testing is performed according to the intended use of the test in the intended patient population for which the test was developed and validated.
  • This includes performing the test using the intended sample types along with parallel testing that must accompany the test (i.e., the meningoencephalitis and bloodstream pathogen tests include requirements for parallel testing using conventional Gram stain and culture-based detection for correlation of results).
  • This also includes the provision - by the laboratory to ordering providers - of the major limitations of a given panel test.
• An evaluation for more than 1 pathogen by NAAT testing is necessary for patient management (testing for a single pathogen is NOT reasonable and necessary for the specific infection, patient, or indication). 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.
• Expanded panel testing is only indicated when targeted panel testing is not appropriate (i.e., will not provide sufficient information for the appropriate clinical management of the patient). See LIMITED COVERAGE FOR EXPANDED (>5 Pathogens) PANEL TESTING below.
• The 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.
  • CV of any new analytes that are not already established as SOC or that do not have a predicate test that is covered by this contractor must be established through a study published in the peer-reviewed literature for the intended use of the test in the intended population.
  • Tests that perform identification of new analytes or are performed according to new intended uses not already covered by this contractor will require a Technical Assessment (TA) for compliance of that service with this policy.
• Documentation of the following is clearly stated in the medical record:
  • Specific clinical indications for testing (i.e., clinical suspicion of a pathogen as the cause of the patient’s condition)
  • Specific reasons for performing panel testing as opposed to single-pathogen testing
  • In the case of expanded panel testing, the specific reasons for performing expanded panel testing as opposed to targeted panel testing
  • Provider type/specialty and Place of Service

Non-Coverage Criteria

Multiplex NAAT Panel Tests will NOT be covered in the following circumstances:

• If the test is performed as a test of cure.
• If the patient has been previously tested by molecular diagnostic methods for the same pathogens within 14 days for the same clinical indication.
  • If a previous panel test was performed with a similar/duplicative intended use, a subsequent test is only reasonable and necessary if the non-duplicative content of the second test is reasonable and necessary.
  • Exception: Repeat panel testing for the same clinical indication will only be covered if first panel yielded a negative result AND there is a high index of suspicion for a pathogen as the cause of symptoms AND the patient’s clinical condition is not improving or is deteriorating after a clinically appropriate length of time. In such cases, 1 additional panel test may be covered between 1 and 14 days after the initial panel test, so long as the test fulfills the criteria for coverage as set forth in this policy.

LIMITED COVERAGE FOR EXPANDED (>5 Pathogens) PANEL TESTING

FOR THE SPECIFIC PANEL TYPES LISTED BELOW, ALL OF THE FOLLOWING ADDITIONAL CRITERIA MUST BE MET:

• Respiratory (RP) and Pneumonia (PNP) Panels will only be covered when targeted testing is not appropriate AND according to the following additional criteria:
  • For immune-competent patients, at least 1 of the following must apply:
    • Testing is ordered by a clinician specialist in Infectious Diseases or Pulmonology for a patient with severe and established underlying respiratory pathology (i.e., severe asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, pulmonary fibrosis, radiation therapy to the lung) AND treatment with antibiotics may be indicated according to established guidelines.1,2 Specific examples that do NOT meet coverage criteria according to established guidelines include the following:
      • Asthma exacerbations without the additional presence of either fever and purulent sputum or radiographic evidence of pneumonia2
      • Uncomplicated community acquired pneumonia (CAP)1
    • The patient is seriously or critically ill (as defined by the American Hospital Association’s “General Guide for the Release of Information on the Condition of Patients”)3 as a result of a presumed respiratory infection AND the patient is being treated in an appropriate critical care facility.
  • For immune-suppressed patients: Testing is ordered by a clinician specialist in 1 of the following: Infectious Diseases, Pulmonology, Oncology, Transplant OR the patient is being managed in an appropriate critical care facility.
  • For ALL patients: Only 1 of the following panels - RP OR PNP- will be covered for a given patient for the same clinical indication. The PNP should be prioritized in the evaluation of pneumonia from lower respiratory tract specimens (i.e., bronchoalveolar lavage samples (BALs)).
• Gastrointestinal (GI) Panels will only be covered when targeted testing is not appropriate AND according to the following additional criteria:
  • For immune-competent patients, at least 1 of the following must apply:
    • Testing is ordered by a clinician specialist in Infectious Diseases or Gastroenterology for a patient with severe and established underlying GI pathology (i.e., inflammatory bowel disease (IBD), paralytic ileus, radiation therapy to the intestine) AND identification of an infectious cause is necessary to determine next steps in patient management.
    • The patient is seriously or critically ill (as defined by the American Hospital Association’s “General Guide for the Release of Information on the Condition of Patients”)3 as a result of a presumed GI infection AND the patient is being treated in an appropriate critical care facility.
    • The patient’s clinical indication for GI panel testing is diarrhea, and ALL of the following apply:
      • The diarrheal illness MUST be acute or persistent with signs or risk factors for severe disease (fever, bloody diarrhea, dysentery, dehydration, severe abdominal pain that may warrant hospitalization) AND/OR not resolving after 7 days, AND
      • The patient has NOT taken laxatives within 24 hours of the test
  • For immune-suppressed patients:
    • Testing is ordered by a clinician specialist in 1 of the following: Infectious Diseases, Gastroenterology, Oncology, Transplant OR the patient is being managed in an appropriate critical care facility.
• Urogenital/Anogenital (UG/AG) Panels
  • For the UG/AG panels, epidemiologic indication or potential exposure to sexually transmitted pathogens (i.e., in the case of clinical concern for multiple sexually transmitted infections (STIs) due to a high-risk experience) is considered a covered clinical indication, even in the absence of clinical symptoms. Documentation of the high-risk reason for panel testing is clearly stated in the medical record.
  • In the absence of a high-risk experience, if the primary clinical concern is for 1 or few specific pathogens due to specific signs and symptoms (i.e., lesions suggestive of herpes simplex virus (HSV)), then it is expected that only a small targeted panel (i.e., including HSV-1 and HSV-2) will be performed. In such cases, expanded panels are NOT considered reasonable and necessary and will NOT be covered.
• Meningoencephalitis (ME) Panels will be covered according to the following additional criteria:
  • For immune-competent patients: the patient has at least 2 of the following indicators of central nervous system (CNS) infection: cerebrospinal fluid (CSF) markers, radiology, clinical signs and symptoms consistent with meningitis or encephalitis, epidemiologic indication or exposure. For immune-compromised patients, at least 1 of these indicators is required.
  • For all patients: Testing is from a sample collected via lumbar puncture, and NOT an indwelling medical device (i.e., CSF shunts).
• Bloodstream Infection (BSI) Panels will be covered according to the following additional criteria:
  • There is clinical concern for bacteremia or sepsis AND microbe(s) were seen on a Gram stain from the patient’s blood AND the patient is being managed in an appropriate critical care facility, AND
  • Personnel (i.e., an antimicrobial stewardship team) are equipped for rapid (same-day) tailoring of antimicrobial therapy as a result of rapid testing
• Urinary Tract Infection (UTI) Panels will be covered according to the following additional criteria:
  • The patient is symptomatic AND at higher risk for UTI complications (i.e., the elderly, patients with recurrent symptomatic UTIs and/or complicated urinary tract anatomy) OR is seen in urogynecology or urology specialty care settings.

Additional information related to specific panels may be found in the related Billing and Coding article.

Tests that demonstrate similar indicated uses and equivalent or superior performance to SOC or other covered tests, as demonstrated in a TA, may similarly be covered under this policy.