Blue Cross Blue Shield RI nucleic acid probe Coverage

Coverage Criteria

Medically necessary organisms (no quantification)

Covered when testing is for the following microorganisms (direct or amplified probe technique without quantification):

listed_microorganisms: Bartonella henselae or quintana; Bordetella pertussis; Candida species; Chlamydia pneumoniae; Chlamydia trachomatis; Clostridium difficile; Enterococcus, vancomycin-resistant (e.g., enterococcus vanA, vanB); Enterovirus; Herpes simplex virus; Human papillomavirus; Influenza virus; Legionella pneumophila; Mumps; Mycobacterium species; Mycobacterium tuberculosis; Mycobacterium avium-intracellulare; Mycoplasma pneumoniae; Neisseria gonorrhoeae; Rubeola (measles); Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); Staphylococcus aureus; Staphylococcus aureus, methicillin-resistant; Streptococcus, group A; Streptococcus, group B; Trichomonas vaginalis; Zika virus

List taken directly from policy

Medically necessary organisms (quantification allowed)

Covered when testing (with or without quantification) is for the following microorganisms:

quantification_microorganisms: Cytomegalovirus; Hepatitis B virus; Hepatitis C virus; HIV-1; HIV-2; Human herpesvirus 6

Quantitative testing (viral load) may be considered

Covered panel

The following panel may be considered medically necessary:

respiratory_panel: Respiratory virus panel (without quantification) may be considered medically necessary

Not covered / Not medically necessary

Not covered or not medically necessary when evidence is insufficient:

not_covered_panels: Central nervous system pathogen panel; Gastrointestinal pathogen panel

These panels are not covered for Medicare Advantage Plans and are not medically necessary for Commercial Products

other_not_covered_microorganisms: Gardnerella vaginalis; Hepatitis G

These microorganisms are considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products

Per the policy excerpt, the central nervous system (CNS) pathogen panel and the gastrointestinal (GI) pathogen panel are explicitly not covered for Medicare Advantage Plans and are stated as not medically necessary for Commercial Products. This exclusion is applied to nucleic acid testing panels (with or without quantification) for these anatomic indications and is supported by the clinical evidence summary in the policy noting insufficient evidence of improved net health outcome for these panels.

The provided excerpt does not list other specific test exclusions beyond the panels named; coverage for any given test or indication is governed by the member's benefit documents (subscriber agreement/certificate or employer agreement). Providers should verify member eligibility and benefits for test coverage and medical necessity prior to ordering.

The policy specifies that the use of nucleic acid testing with quantification (e.g., viral load) for microorganisms that are not included in the policy's listed covered organisms is considered not medically necessary for Commercial Products and not covered for Medicare Advantage Plans when available evidence is insufficient to demonstrate improved net health outcome.

Services determined to be not medically necessary or otherwise non-covered benefits may be denied and can result in potential member financial liability unless the member has provided informed written agreement in advance. Additionally, laboratories may not obtain prior authorization on behalf of the ordering physician; failure to follow authorization procedures can result in denial and financial liability assigned to the laboratory.

Covered Indications

Testing for the specific microorganisms and panels listed

Testing for the specific microorganisms and panels listed (see covered microorganisms and covered CPT codes). Proprietary Laboratory Analyses (PLA) tests below may be considered medically necessary when the medical criteria above are met and prior authorization is obtained.

pla_list: MicroGenDX qPCR & NGS For Infection (MicroGenDX) — CPT 0112U; ePlex BCID Fungal Pathogens Panel (GenMark) — CPT 0140U; ePlex BCID Gram-Positive Panel (GenMark) — CPT 0141U; ePlex BCID Gram-Negative Panel (GenMark) — CPT 0142U

Prior authorization required for these PLA tests

Detection of GI, respiratory, and other infectious pathogens using multiplex nucleic acid tests

Detection of gastrointestinal, respiratory, and other infectious pathogens using multiplex nucleic acid tests when clinically indicated, supported by referenced studies and guidelines:

multiplex_evidence: Multiplex gastrointestinal and respiratory nucleic acid panels and other multiplex molecular assays may be used to detect multiple pathogens simultaneously when clinically indicated; utilization is supported by cited evaluations, systematic reviews, randomized trials, and guideline documents referenced in the policy.

Coding

Covered CPT Codes (PLA) - MicroGenDXCPTCovered

0112U

Infectious agent detection and identification, targeted sequence analysis (16S and 18S rRNA genes) with drug-resistance gene (MicroGenDX qPCR & NGS For Infection)

Covered CPT Codes (PLA) - ePlex FungalCPTCovered

0140U

Infectious disease (fungi), fungal pathogen identification, DNA (15 fungal targets), blood culture, amplified probe technique, each target reported as detected or not detected (ePlex BCID Fungal Pathogens Panel)

Covered CPT Codes (PLA) - ePlex Gram-PositiveCPTCovered

0141U

Infectious disease (bacteria and fungi), gram-positive organism identification and drug resistance element detection, DNA (20 gram-positive bacterial targets, 4 resistance genes, 1 pan gram-negative bacterial target, 1 pan Candida target), blood culture, amplified probe technique, each target reported as detected or not detected (ePlex BCID Gram-Positive Panel)

Covered CPT Codes (PLA) - ePlex Gram-NegativeCPTCovered

0142U

Infectious disease (bacteria and fungi), gram-negative bacterial identification and drug resistance element detection, DNA (21 gram-negative bacterial targets, 6 resistance genes, 1 pan gram-positive bacterial target, 1 pan Candida target), amplified probe technique, each target reported as detected or not detected (ePlex BCID Gram-Negative Panel)

Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for the following Proprietary Laboratory Analyses (PLA) tests listed below. The ordering physician must obtain authorization; laboratories are not permitted to obtain authorization or participate in the authorization process on behalf of the ordering physician.

MicroGenDX qPCR & NGS For Infection (MicroGenDX) — CPT 0112U
ePlex BCID Fungal Pathogens Panel (GenMark Diagnostics, Inc.) — CPT 0140U
ePlex BCID Gram-Positive Panel (GenMark Diagnostics, Inc.) — CPT 0141U
ePlex BCID Gram-Negative Panel (GenMark Diagnostics, Inc.) — CPT 0142U

Note

Prior Authorization Guidance

This policy is governed by the member's benefit documents (subscriber agreement, certificate, and/or employer agreement). BCBSRI may review and revise this policy at any time. For member-specific benefits and eligibility verification, contact the provider call center.

Ordering Requirements

Documentation Required

Ordering physician must manage prior authorization and appeals; labs may not obtain authorization

Only the ordering physician shall be involved in prior authorization and appeals; laboratories are prohibited from obtaining authorization on the ordering physician's behalf.

Do not use laboratory representatives or third parties to obtain or facilitate authorization or appeals.
BCBSRI may take severe action, up to termination from the network, if a laboratory is found to support authorization improperly.

Note

Ordering authority not specified in excerpt — refer to full policy

The excerpt does not specify who may order these tests; refer to the full policy or member documents for ordering authority and any additional ordering requirements.

Consult the full medical policy or member benefit documents for details on ordering authority.

Not Covered / Exclusions

The policy expressly lists the central nervous system pathogen panel and the gastrointestinal pathogen panel as not covered for Medicare Advantage Plans and as not medically necessary for Commercial Products in the excerpt, supported by the policy's review of the evidence base for those panels.

No additional specific tests or clinical indications are enumerated as explicit exclusions in the excerpt beyond those named panels. Final coverage determinations remain subject to the member's benefit documents and medical necessity review; contact the provider call center or refer to subscriber/employer agreements for member-specific coverage details.

Background

Nucleic acid probe testing detects organism-specific DNA or RNA and may be performed using direct probe techniques, amplified probe techniques (e.g., PCR and multiplex PCR variants), or quantitative/real-time methods that provide viral-load style measurements. Amplified techniques increase analytical sensitivity compared with direct probes, and quantitative methods generate absolute or relative amounts of target nucleic acid useful for prognosis or monitoring in selected infections.

Definitions

inv-23: Direct probe technique — detection of nucleic acids without an initial amplification step

DefinitionDetection of nucleic acids without an initial amplification step.

Clinical noteDirect assays generally have lower sensitivity than amplified probe techniques; indications for direct and amplified probes without quantification are considered together in this policy.

Examples / contextUsed to directly identify organism DNA or RNA when amplification is not performed; most commercially available probes are amplified (exceptions exist).

inv-24: Amplified probe technique — detection methods using target/probe/signal amplification to improve sensitivity without quantification

DefinitionDetection methods in which target, probe, or signal amplification is used to improve assay sensitivity over direct probe techniques, without quantification of nucleic acid amounts.

Frequency Limits

inv-29: (Frequency limits placeholder) — block reserved for any frequency limits or repeat testing intervals noted in policy

Frequency limitsNo specific frequency limits or repeat testing intervals are listed in this policy excerpt.

GuidanceBenefits and coverage may vary by contract; refer to the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for any plan-specific limits.

Action for providersVerify member benefits and any laboratory benefit restrictions prior to ordering repeat or serial testing.

Revision History

2024-01-01effective_date

Policy effective date set to 2024-01-01.

2023-06-09last_review

Policy last reviewed on 2023-06-09.

2024-06-09next_reviewLatest

Next scheduled review on 2024-06-09.

OpenPayer

Identification of Microorganisms Using Nucleic Acid Probes