CurrentLA Care HealthPolicy N/A

Molecular Diagnostic Test for Respiratory Pathogen Testing

Defines L.A. Care's medical necessity criteria for outpatient molecular (NAAT/PCR) respiratory viral testing, including limits on panel size, patient risk status, documentation and laboratory requirements, and lists CPT/HCPCS codes considered not medically necessary.

Policy Summary

PayerLA Care Health

PolicyMolecular Diagnostic Test for Respiratory Pathogen Testing

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionDocument in the medical record specific clinical indications, reasons for panel testing, provider specialty and place of service, and that testing is ordered per manufacturer's intended use; testing must be ordered by a qualified practitioner actively managing the patient.

POLICY UPDATE CHANGES

No material clinical/coverage changes

<=5Allowed panel targets (medically necessary)

>=6Large panel targets (not medically necessary)

10+Example listed EUA/cleared panels included in not medically necessary codes

Coverage Summary

Scope: Outpatient molecular (NAAT/PCR) respiratory pathogen testing including single-target and multiplex panels. Coverage stance: mixed — limited panels are allowed in specific outpatient situations while larger multiplex panels are considered not medically necessary. Thresholds: outpatient testing is considered medically necessary when using panels with <= 5 targets and is considered not medically necessary for panels with >= 6 targets. Specific CPT/HCPCS panel codes for larger multiplex respiratory NAATs are listed as not medically necessary.

Medical-Necessity Criteria

Medically Necessary — Outpatient respiratory viral single or multiplex testing

Considered medically necessary when ALL of the following are met:

ALL of the following

Use of limited panels involving 5 targets or less
Clinical concern for a symptomatic respiratory viral infection
Testing is for individuals who are at high risk for complications of respiratory viral infection (including, but not limited to, immunocompromised individuals, e.g., lung transplant recipients)
The results of testing will be used to guide or alter management
The outpatient setting is equipped to deliver timely results
Ordered by a qualified health care practitioner practicing within the scope of their license and who is actively managing the individual's care
Documentation requirements (ALL must be documented in the medical record)
- Specific clinical indications for testing (i.e., clinical suspicion of a pathogen as the cause of the medical condition)
- Specific reasons for performing panel testing
- Provider type/specialty and Place of Service
- Ordered and performed according to test manufacturer's intended indications for use
- Performed by a CLIA-certified high- or medium-complexity or CLIA-waived laboratory if so directed by test Instructions for Use
Not billed with Place of Service codes 19, 21, 22, 23

Not Medically Necessary — Outpatient respiratory viral panel testing

Considered not medically necessary when ANY of the following are present (or when above criteria are not met):

ANY of the following

Testing average risk individuals
Use of large panels involving 6 or more targets
Failure to meet any of the medically necessary criteria listed above

Coding

Codes considered not medically necessary (respiratory multiplex NAAT/panel codes)CPTNot Covered

87632	Infectious agent detection by nucleic acid (DNA or RNA); respiratory virus, multiple types/subtypes, 6-11 targets
87633	Infectious agent detection by nucleic acid (DNA or RNA); respiratory virus, multiple types/subtypes, 12-25 targets
0115U	Respiratory infectious agent detection by nucleic acid (DNA and RNA), 18 viral types and 2 bacterial targets, ePlex Respiratory Pathogen (RP) Panel
0202U	Pathogen-specific nucleic acid, 22 targets including SARS-CoV-2, BioFire Respiratory Panel 2.1
0223U	Pathogen-specific nucleic acid, 22 targets including SARS-CoV-2, QIAstat-Dx Respiratory SARS CoV-2 Panel
0225U	Pathogen-specific DNA and RNA, 21 targets, ePlex Respiratory Pathogen Panel 2
0528U	Lower respiratory tract infectious agent detection, multiple bacteria/viruses and resistance genes, BIOFIRE FILMARRAY Pneumonia Panel
0556U	Pathogen-specific DNA and RNA by real-time PCR, 12 targets, HealthTrackRx Bronchitis
0563U	Pathogen-specific nucleic acid, 11 viral and 4 bacterial targets
0564U	Pathogen-specific nucleic acid, 10 viral and 4 bacterial targets, BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel

Provider Actions

Documentation Required

Medical necessity documentation required

Document in the medical record specific clinical indications, reasons for panel testing, provider specialty and Place of Service, and that testing is ordered per the test manufacturer's intended indications for use. Testing must be ordered by a qualified health care practitioner who is actively managing the individual's care.

Specific clinical indications for testing
Specific reasons for performing panel testing
Provider type/specialty and Place of Service
Ordered and performed according to manufacturer's intended indications for use
Ordered by a qualified practitioner actively managing the patient's care

Billing Rule

Place of Service restriction

Do not bill respiratory outpatient molecular testing with Place of Service codes 19, 21, 22, 23.

Documentation Required

Laboratory complexity requirement

Testing must be performed by a CLIA-certified high- or medium-complexity laboratory, or by a CLIA-waived laboratory when so directed by the test Instructions for Use.

Background

Molecular (NAAT/PCR) culture-independent diagnostic tests detect pathogen nucleic acid without culture, offering shorter turnaround times, strong test performance, and lower technical requirements compared with traditional methods (viral culture, serology, DFA). The number of FDA-cleared multiplex respiratory pathogen panels has increased substantially, and these panels can simultaneously detect multiple viruses and some bacterial targets. In the outpatient setting, these tests can aid diagnosis and management when results are available in a timely manner and when used according to intended indications and clinical need.

Definitions

Acute Respiratory InfectionA viral or bacterial infection affecting the upper or lower respiratory tract that lasts less than 30 days; examples include common cold, sinusitis, pharyngitis, otitis media, laryngitis, pneumonia, bronchitis, bronchiolitis.

Antigen TestingLaboratory test that detects specific proteins (antigens) on the surface of a virus or bacteria.

Molecular Diagnostic TestingLaboratory test using nucleic acid amplification techniques (e.g., PCR) to detect genetic material (DNA or RNA) of viruses or bacteria from patient samples.

Evidence and guidance: professional societies and literature support molecular testing for acute respiratory infections and describe clinical uses and impacts. Key references include IDSA and ATS guidelines and reviews (Clin Infect Dis, Am J Respir Crit Care Med, Clin Microbiol Rev) and CMS MolDx local coverage articles (L39001 & L39003) addressing molecular syndromic panels and coverage considerations.

Name	Number	Type	Effective Date
MolDX: molecular syndromic panels for infectious disease pathogen identification testing	L39001 & L39003	LCD	2022-04-17