priority health Infectious Disease Panels Coverage

Coverage Criteria for Molecular Infectious Disease Panels

General medical necessity criteria

Infectious disease pathogen molecular panels are medically necessary when ALL of the following are met:

General criteria: 1. Testing is performed according to the intended use of the test in the intended patient population for which the test was developed and validated; 2. Tests demonstrate equivalent or superior analytical and clinical validity to established standard-of-care methods for included targets (e.g., culture, pathogen-specific PCR); 3. The results will impact clinical management as demonstrated in peer-reviewed literature and improve patient outcomes; 4. Evaluation for more than one pathogen by molecular testing is necessary for the member's management (single-pathogen testing is not reasonable/necessary) and the panel includes at least the minimum pathogens required for clinical decision making for its intended use; 5. Expanded panel testing is only indicated when targeted panel testing is not appropriate (i.e., targeted testing would not provide sufficient information for appropriate clinical management); 6. The member has a clinical indication for infectious disease testing; 7. Documentation in the medical record of specific clinical indications and why multi-pathogen testing is necessary (or why single-pathogen testing is not reasonable/necessary); 8. Testing performed according to CLIA and/or FDA regulations and consistent with intended-use labeling.

General coverage preconditions for all panels

Gastrointestinal pathogen panel (GIPP) Coverage — ANY of the following (and general criteria)

Gastrointestinal pathogen panel (GIPP): covered when ANY of the following clinical indications are met (and general criteria are met):

GIPP indications: a. Acute diarrhea with moderate-to-severe symptoms (such as fever, dysentery, severe dehydration); b. Gastrointestinal infection with moderate-to-severe symptoms (such as fever, dysentery, severe dehydration); c. Community-acquired diarrhea that persists >7 days, or travel-associated diarrhea of uncertain etiology; d. Immunocompromised individuals with acute diarrhea or moderate-to-severe GI infection (immunocompromise may support panels with ≥12 pathogens).

GIPP specific covered indications

GIPP Not Medically Necessary — ANY of the following apply

GIPP not medically necessary when ANY of the following apply:

GIPP not medically necessary: a. Immunocompetent individuals with mild diarrhea, particularly of ≤7 days' duration; b. Clinical presentation suggests a specific infectious etiology unless first-line testing fails to detect the suspected organism and high clinical suspicion remains; c. More than one type of test for the same organism on the same date of service or within 7 days is not medically necessary.

GIPP exclusions

Targeted respiratory/pneumonia panel coverage — targeted panels (up to 5 pathogens) medically necessary when ALL are met

Respiratory (RP) and Pneumonia (PNP) targeted panels (up to and including 5 pathogens) are medically necessary when ALL of the following are met:

Targeted RP/PNP criteria: a. The general criteria for infectious disease pathogen molecular panels are met; b. Member is immunocompetent; c. Member has severe and established underlying respiratory pathology (e.g., severe asthma, COPD, cystic fibrosis, pulmonary fibrosis, prior lung radiation); d. Treatment with antibiotics may be indicated according to established guidelines.

Conditions for targeted respiratory/pneumonia panel coverage

Respiratory/Pneumonia Not Medically Necessary conditions

Respiratory/pneumonia panel testing is not medically necessary in the following situations:

RP/PNP not medically necessary: a. Panel testing for asthma exacerbations without fever and purulent sputum or radiographic evidence of pneumonia; b. Panel testing for uncomplicated community-acquired pneumonia (CAP); c. Expanded panels (6 or more targets) are not medically necessary.

Respiratory exclusions; only one panel covered per member per clinical indication

Urogenital/Anogenital panels coverage rules

Urogenital/Anogenital (UG/AG) panel coverage rules:

STI panel coverage: a. General criteria are met; and either b. Member has epidemiologic indication or potential exposure to STIs with documentation of high-risk reason in the medical record (asymptomatic testing supported when high-risk exposure documented); OR c. If no high-risk exposure but clinical concern targets a few specific pathogens, targeted panels (<5 pathogens) may be medically necessary. Expanded panels (6 or more targets) are considered not medically necessary.

STI panel criteria

Vaginitis/vaginosis testing: a. General criteria are met; b. Targeted panels for diagnosis of a symptomatic member are medically necessary. Expanded panels (6 or more targets) are considered not medically necessary.

Vaginitis/vaginosis criteria

Application to products — coverage subject to member's benefits and plan documents

Coverage is subject to the member's specific benefits and plan documents; group-specific policy will supersede this policy when applicable.

Plan applicability: Applies to insured HMO/EPO, POS, PPO, ASO, Individual, Medicare, and Medicaid/Healthy Michigan Plan as specified; if there is a conflict, the applicable plan document or CMS determination governs. Coverage is determined in accordance with the member's plan in effect on the date of service.

See product application details in policy.

Regulatory precedence — Federal and CMS determinations take precedence

Federal and CMS determinations take precedence over this policy.

Regulatory precedence: Any applicable federal or state mandates and CMS National or Local Coverage Determinations (NCDs/LCDs/LCAs) override this medical coverage policy; consult the CMS Medicare Coverage Database for current guidance.

Refer to CMS for most current NCD/LCD/LCA guidance.

Coverage linkage for specified CPT codes — Covered only when ALL of the following are met

The following CPT codes are covered only when ALL of the conditions below are met:

Diagnosis requirement: When billing CPT codes 81513, 81514, or 81515, the service is covered only when billed with one of the specified ICD-10 diagnosis codes listed in the policy (urogenital/anogenital infection and related codes). Documentation must support one of the allowed ICD-10 codes.

See ICD-10 lists in policy chunks 42-44 for allowed codes.

Panels intended for home use (including FDA-cleared home tests), panels performed solely as a test of cure, panels used only to confirm a known diagnosis, panels intended to determine risk for developing disease, or the use of a panel without diagnosis-specific indications are listed as not medically necessary. Also not medically necessary are performing more than one panel on the same date of service for the same clinical indication, using a panel that lacks the minimum pathogens required for clinical decision making, and using expanded panels when the primary clinical concern is for a specific pathogen that could be evaluated with targeted testing.

Expanded respiratory panels that include 6 or more targets are considered not medically necessary. The policy explicitly lists common commercial platforms as examples of expanded panels that are not covered, including the BioFire FilmArray Respiratory Panel (RP) and RP2.1, ePlex Respiratory Pathogen (RP) Panels, NxTAG Respiratory Pathogen Panels, and the QIAstat-Dx Respiratory SARS-CoV-2 Panel. Panel testing for routine asthma exacerbations or uncomplicated community-acquired pneumonia is also noted as not medically necessary absent other qualifying findings.

The policy enumerates numerous procedure and U-codes that are designated as non-covered. Examples include whole genome bacterial strain typing (0010U), Accelerate PhenoTest BC Kit related codes (0086U, 0311U), broad NGS or large respiratory panels (0152U, 0202U, 0223U, 0225U), and other proprietary or high-target-count assays such as 0321U, 0323U, 0330U, 0480U, 0531U, and similar listed codes. See the Non-Covered Procedures list in the policy for the full set of specific codes.

Billing CPT codes 81513, 81514, and 81515 without documentation linking the service to one of the ICD-10 diagnosis codes listed in the policy will not meet the coverage condition for those codes. Providers should verify that claims for these codes include an allowed ICD-10 diagnosis as enumerated in the policy prior to submission.

This policy is informational and subject to the member's specific benefits and plan documents. Coverage is contingent on satisfaction of all plan terms and conditions, and group-specific policy or applicable CMS/state mandates will supersede this policy when applicable. Providers remain responsible for confirming applicability to the member's product and for documenting medical necessity in the medical record.

Expanded multiplex panels that detect 6 or more targets are generally considered not medically necessary for many common clinical indications (for example, immunocompetent mild diarrhea, routine asthma exacerbation, or uncomplicated CAP). Targeted testing (panels with up to 5 pathogens or single-pathogen assays) is preferred when the clinical presentation suggests a specific etiology or when results would not change management if additional low-yield targets were included.

The policy designates a set of specific novel or proprietary expanded panels and certain proprietary assays as non-covered procedures. These include, but are not limited to, high-target-count respiratory and broad NGS panels and other named U-codes listed in the Non-Covered Procedures section (for example, 0010U, 0152U, 0202U, 0225U, 0321U, 0480U, 0531U). Such assays are treated as non-covered by this policy and should not be billed for coverage without prior agreement from the plan.

Procedure and Billing Codes

Listed CPT/HCPCS/U codes (selection)mixed

0402U

Infectious agent (sexually transmitted infection), Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium, multiplex amplified probe technique, vaginal, endocervical, or male urine, each pathogen reported as detected or not detected

Covered / referenced codesmixedCovered

0483U	Infectious disease (Neisseria gonorrhoeae), sensitivity, ciprofloxacin resistance (gyrA S91F point mutation), oral, rectal, or vaginal swab, algorithm reported as probability of fluoroquinolone resistance
0484U	Infectious disease (Mycoplasma genitalium), macrolide sensitivity (23S rRNA point mutation), oral, rectal, or vaginal swab, algorithm reported as probability of macrolide resistance
0527U	Herpes simplex virus (HSV) types 1 and 2 and Varicella zoster virus (VZV), amplified probe technique, each pathogen reported as detected or not detected
0615U	Borrelia burgdorferi (Lyme disease), antibody detection of 26 recombinant protein groups, by immunoassay, IgM
87505	Infectious agent detection by nucleic acid (DNA or RNA); gastrointestinal pathogen, multiple types or subtypes, 3-5 targets
87506	Infectious agent detection by nucleic acid; gastrointestinal pathogen, 6-11 targets
87507	Infectious agent detection by nucleic acid; gastrointestinal pathogen, 12-25 targets
87494	Chlamydia trachomatis and Neisseria gonorrhoeae, multiplex amplified probe technique
87627	Infectious agent detection by nucleic acid; joint space pathogens and drug resistance genes, 26 or more targets
87631	Respiratory virus, 3-5 targets

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Non-Covered Procedures (explicitly listed)mixedNot Covered

0010U	Infectious disease (bacterial), strain typing by whole genome sequencing, phylogenetic-based report of strain relatedness, per submitted isolate
0086U	Organism identification, blood culture, using rRNA FISH, 6 or more organism targets, reported as positive or negative with phenotypic MIC-based antimicrobial susceptibility [Accelerate PhenoTest BC Kit]
0112U	Infectious agent detection and identification, targeted sequence analysis (16S and 18S rRNA genes) with drug-resistance gene
0115U	Respiratory infectious agent detection by nucleic acid (DNA and RNA), 18 viral types and subtypes and 2 bacterial targets, amplified probe technique
0152U	Infectious disease DNA PCR and NGS, plasma, detection of >1,000 potential microbial organisms
0202U	Respiratory pathogen-specific nucleic acid, 22 targets including SARS-CoV-2, qualitative RT-PCR, nasopharyngeal swab
0223U	Respiratory pathogen-specific nucleic acid, 22 targets including SARS-CoV-2, qualitative RT-PCR, nasopharyngeal swab
0225U	Pathogen-specific DNA and RNA, 21 targets, amplified probe technique, each analyte reported as detected or not detected
0311U	Quantitative antimicrobial susceptibility reported as phenotypic MIC-based AST [Accelerate PhenoTest BC Kit AST]
0321U	Genitourinary pathogens identification of 20 bacterial and fungal organisms and 16 antibiotic-resistance genes

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Enumerated molecular panel and related procedure codesmixed

0321U	Infectious agent detection by nucleic acid (DNA or RNA), genitourinary pathogens, identification of 20 bacterial and fungal organisms and identification of 16 associated antibiotic-resistance genes, multiplex amplified probe technique
0323U	Infectious agent detection by nucleic acid (DNA and RNA), central nervous system pathogen, metagenomic next-generation sequencing, cerebrospinal fluid (CSF), identification of pathogenic bacteria, viruses, parasites, or fungi
0330U	Infectious agent detection by nucleic acid (DNA or RNA), vaginal pathogen panel, identification of 27 organisms, amplified probe technique, vaginal swab
0351U	Infectious disease (bacterial or viral), biochemical assays, TRAIL, IP-10, and C-reactive protein, serum, algorithm reported as likelihood of bacterial infection
0371U	Infectious agent detection by nucleic acid (DNA or RNA), genitourinary pathogen, semiquantitative identification, DNA from 16 bacterial organisms and 1 fungal organism, multiplex amplified probe technique via qPCR, urine
0372U	Infectious disease (genitourinary pathogens), antibiotic-resistance gene detection, multiplex amplified probe technique, urine, reported as an antimicrobial stewardship risk score
0427U	Monocyte distribution width, whole blood (List separately in addition to code for primary procedure)
0441U	Infectious disease (bacterial, fungal, or viral infection), semiquantitative biomechanical assessment (via deformability cytometry), whole blood, with algorithmic analysis and result reported as an index [IntelliSep]
0442U	Infectious disease (respiratory infection), Myxovirus resistance protein A (MxA) and C-reactive protein (CRP), fingerstick whole blood specimen, each biomarker reported as present or absent [FebriDx configuration]
0480U	Infectious disease (bacteria, viruses, fungi, and parasites), CSF, metagenomic next generation sequencing (DNA and RNA), bioinformatic analysis, with positive pathogen identification

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CPT codes covered only with specified ICD-10 diagnosis codesCPTCovered

81513	Infectious disease, bacterial vaginosis, quantitative real-time amplification of RNA markers for Atopobium vaginae, Gardnerella vaginalis, and Lactobacillus species
81514	Infectious disease, bacterial vaginosis and vaginitis, quantitative real-time amplification of DNA markers including Gardnerella, Atopobium, Megasphaera, with separate detection of Trichomonas and Candida species when reported
81515	Infectious disease, bacterial vaginosis and vaginitis, real-time PCR amplification of DNA markers for Atopobium, Megasphaera, BVAB-2, reported as likelihood of bacterial vaginosis; includes separate detection of Trichomonas and Candida species when reported

CPT and billing statementmixed

No codes listed

inv-23: BioFire RP2.1 run time and targets

Run timeApproximately 45 minutes per run

Number of targetsIncludes 22 respiratory viral and bacterial targets

Platform compatibilityIntended for use with BioFire FilmArray 2.0 or BioFire FilmArray Torch systems

inv-24: ePlex/BioFire performance metrics

ePlex agreementOverall agreement with BioFire FilmArray comparator >95% for all targets

ePlex PPA range

Provider Responsibilities, Documentation, and Prior Authorization

Prior Authorization

Prior Authorization for Medical Necessity

Prior authorization may be required for certain tests, services, or procedures. When prior authorization is required, the provider must submit a request demonstrating the medical necessity of the service per Priority Health requirements. Failure to obtain required prior authorization may result in denial or delay of payment. Refer to the Priority Health Provider Manual for detailed prior authorization procedures and lists of services requiring prior authorization.

Providers should verify prior authorization requirements before performing testing.
Requests must document how the test meets medical necessity criteria in the policy (e.g., intended use, validated population, impact on clinical management).
Denials may occur if prior authorization is not obtained when required.

Prior Authorization

Diagnosis-Linked Coverage — Confirm Prior Authorization

Certain molecular panel CPT codes are covered only when linked to an allowed ICD-10 diagnosis. Providers must confirm coverage by ensuring the submitted ICD-10 code supports medical necessity for the specific CPT code and, when required, obtain prior authorization. Lack of an allowed ICD-10 or failure to confirm prior authorization when required may result in claim denial.

Background and Scope

Molecular nucleic acid amplification tests (NAAT/PCR) enable simultaneous detection of multiple pathogens with faster turnaround and higher sensitivity compared with traditional culture-based methods. Highly multiplexed assays can detect co-infections and a broad range of organisms; however, clinical utility depends on the clinical context (severity, duration, immune status) and whether results will change management. Examples of commercially available multiplex respiratory platforms and performance characteristics are discussed in the policy background (for example, reported high agreement for ePlex and high sensitivity/specificity for BioFire RP2.1).

Definitions and Test Types

inv-43: NAAT / NAT definition

DefinitionNucleic acid amplification test (NAAT/NAT): genetic tests that amplify microbial genetic material to detect pathogens (includes PCR and related methods)

PurposeUsed to detect pathogen-specific DNA/RNA with high sensitivity and faster turnaround versus culture

ExamplesIncludes PCR-based assays and next-generation sequencing (mNGS) approaches when amplification is used

inv-44: Targeted vs expanded panels definition

Targeted panelsSmaller panels typically detect approximately 3–5 pathogens

Expanded/large panelsCommercially available larger panels detect ~20 targets or more and may include pathogens across different syndromes

OpenPayer

Infectious Disease Molecular Panels

Coverage Criteria for Molecular Infectious Disease Panels

Procedure and Billing Codes

Provider Responsibilities, Documentation, and Prior Authorization

Background and Scope

Definitions and Test Types