ModifiedCommunity Care Independent Practice AssociationPolicy CP.MP.209

Gastrointestinal Pathogen Nucleic Acid Detection Panel Testing

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This policy governs medical necessity, clinical criteria, documentation, and coding for multiplex gastrointestinal pathogen nucleic acid detection panel testing in stool specimens. It applies to providers submitting testing for members or enrollees of health plans affiliated with Centene Corporation.

Policy Summary

PayerCommunity Care Independent Practice Association

PolicyGastrointestinal Pathogen Nucleic Acid Detection Panel Testing

Policy CodePolicy CP.MP.209

Change TypeAnnual review revision

Effective DateN/A

Last ReviewMar 1, 2023

Next Review DateN/A

Key ActionReview all applicable Medicare National Coverage Determinations, Local Coverage Determinations, and Medicare Coverage Articles before applying this policy's criteria for Medicare members or enrollees.

SourceLink

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ModifiedCommunity Care Independent Practice AssociationPolicy CP.MP.209

Gastrointestinal Pathogen Nucleic Acid Detection Panel Testing

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Policy Summary

PayerCommunity Care Independent Practice Association

PolicyGastrointestinal Pathogen Nucleic Acid Detection Panel Testing

Policy CodePolicy CP.MP.209

Change TypeAnnual review revision

Effective DateN/A

Last ReviewMar 1, 2023

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

The March 2023 annual review replaced the prior criteria with current criteria in sections I and II and removed section III.

Deleted code 0097U was removed from the policy.

CPT code 87506 was moved from Table 1 to Table 2.

Place of Service Code 19 and ICD-10 diagnosis-code Tables 4, 5, and 6 were added to support medical-necessity determinations.

The policy replaced the term PCR with GI pathogen panel testing in the note below Table 3.

The background was updated and extraneous language was reworded without clinical impact on the criteria.

≤5Standard panel target limit

>6Expanded panel threshold

3ICD-10 diagnosis tables added

19Place-of-service code added

1Deleted billing code removed

Medical Necessity Criteria

Panels with five or fewer targets

Gastrointestinal pathogen panel testing of five or fewer targets is considered medically necessary when ALL of the following criteria are met.

ALL of the following

ONE clinical indication
- The member/enrollee is immunocompetent, and there is a presumption of active infection or infection-associated complications, which may include exacerbation of underlying disease, requiring identification of a causative organism for appropriate management. Atypical clinical presentations are appropriate indications for special populations who may not present with classic symptoms of infection, such as elderly patients.
- The member/enrollee is immunocompromised, including individuals with HIV/AIDS; those taking immunosuppressive medications such as chemotherapy, biologics, transplant-related immunosuppressive drugs, or high-dose systemic corticosteroids; or those with inherited immune-system diseases such as congenital immunoglobulin deficiencies. Atypical clinical presentations are appropriate indications for testing. Testing may be performed once as part of a pre-transplant evaluation, regardless of the presence of symptoms.
Testing results will impact clinical management in a manner already demonstrated in peer-reviewed published literature to improve patient outcomes.
Testing is performed according to the intended use of the test and in the intended population for which the test was developed and validated.
Targeted testing is not appropriate because it will not provide sufficient information for appropriate clinical management.
The panel includes at least the minimum pathogens required for clinical decision-making for its intended use that can be reasonably detected by the test.
The registered test demonstrates equivalent or superior analytical validity (AV) and clinical validity (CV) compared with established standard-of-care methods, such as culture or pathogen-specific polymerase chain reaction (PCR), for the majority of targets included on the panel.
Required medical-record documentation
- Specific clinical indications for testing are clearly documented, including clinical suspicion of a pathogen as the cause of the patient's condition.
- Specific reasons for performing panel testing are clearly documented.
- The provider type or specialty and place of service are clearly documented.

Panels with greater than six targets

Expanded gastrointestinal pathogen panel testing of greater than six targets is considered medically necessary when ALL of the following are met.

ALL of the following

All criteria in the 'Panels with five or fewer targets' section are met.
At least ONE additional qualifying criterion
- The member/enrollee is immunocompromised, as defined in the clinical-indication criteria above.
- The member/enrollee is immunocompetent AND one of the following applies
  - Testing is ordered for a patient with severe and established underlying gastrointestinal pathology, such as inflammatory bowel disease (IBD), paralytic ileus, or radiation therapy to the intestine, and identification of an infectious cause is necessary to determine the next steps in clinical management.

Covered Clinical Indications

Presumed Active Gastrointestinal Infection or Infection-Associated Complication

Gastrointestinal pathogen panel testing is medically necessary when a causative organism must be identified for appropriate management of presumed active gastrointestinal infection or an infection-associated complication.

Qualifying clinical indication

Immunocompetent member
- The member is immunocompetent and has presumed active gastrointestinal infection or an infection-associated complication, which may include exacerbation of underlying disease, requiring identification of a causative organism for appropriate management.
- Clinical presentation
  - The member has a typical clinical presentation of suspected infection.
  - The member has an atypical clinical presentation and is in a special population, such as an older adult, who may not present with classic symptoms of infection.

Testing Frequency

Frequency limit

TestGastrointestinal pathogen panel testing

FrequencyOnce

Applies whenAs part of a pre-transplant evaluation, regardless of the presence of symptoms

Coding and Billing Requirements

Table 1: CPT codes that support medical necessity in any place of service and with any diagnosisCPTCovered

87505

Infectious agent detection by nucleic acid (DNA or RNA); gastrointestinal pathogen (eg, Clostridium difficile, E. coli, Salmonella, Shigella, norovirus, Giardia), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 3-5 targets

Table 2: CPT codes that support medical necessity when billed with applicable place of service and diagnosis codesCPTCovered

87506	Infectious agent detection by nucleic acid (DNA or RNA); gastrointestinal pathogen (eg, Clostridium difficile, E. coli, Salmonella, Shigella, norovirus, Giardia), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 6-11 targets
87507	Infectious agent detection by nucleic acid (DNA or RNA); gastrointestinal pathogen (eg, Clostridium difficile, E. coli, Salmonella, Shigella, norovirus, Giardia), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 12-25 targets

Table 3: Place of service codes supporting medical necessity for codes in Table 2ModifierCovered

19	Off Campus- Outpatient Hospital
21	Inpatient Hospital
22*	Outpatient Hospital (Observation)
23	Emergency Room - Hospital

Table 4: ICD-10 diagnosis codes that support medical necessity for a CPT code in Table 2 when also billed with an ICD-10 diagnosis code in Table 5ICD-10Covered

A00.0	Cholera due to Vibrio cholerae 01, biovar cholerae
A00.1	Cholera due to Vibrio cholerae 01, biovar eltor
A00.9	Cholera, unspecified
A01.00	Typhoid fever, unspecified
A01.09	Typhoid fever with other complications
A01.1	Paratyphoid fever A
A01.2	Paratyphoid fever B
A01.3	Paratyphoid fever C
A02.0	Salmonella enteritis
A02.8	Other specified salmonella infections

1–10 of 49

1/5

Table 5: ICD-10 diagnosis codes that support medical necessity for a CPT code in Table 2 when also billed with an ICD-10 diagnosis code in Table 4ICD-10Covered

B20	Human immunodeficiency virus [HIV] disease
B25.1	Cytomegaloviral hepatitis
B25.2	Cytomegaloviral pancreatitis
C46.0	Kaposi's sarcoma of skin
C46.1	Kaposi's sarcoma of soft tissue
C46.2	Kaposi's sarcoma of palate
C46.3	Kaposi's sarcoma of lymph nodes
C46.4	Kaposi's sarcoma of gastrointestinal sites
C46.50	Kaposi's sarcoma of unspecified lung
C46.51	Kaposi's sarcoma of right lung

ICD-10 diagnosis codes supporting medical necessityICD-10Covered

A04.6	Enteritis due to Yersinia enterocolitica
A04.71	Enterocolitis due to Clostridium difficile, recurrent
A04.72	Enterocolitis due to Clostridium difficile, not specified as recurrent
A04.8	Other specified bacterial intestinal infections
A04.9	Bacterial intestinal infection, unspecified
A05.0	Foodborne staphylococcal intoxication
A05.1	Botulism food poisoning
A05.2	Foodborne Clostridium perfringens intoxication
A05.3	Foodborne Vibrio parahaemolyticus intoxication
A05.4	Foodborne Bacillus cereus intoxication

1–10 of 114

1/12

ICD-10 diagnosis codes supporting medical necessity when billed with a CPT code in Table 2ICD-10Covered

E08.43	Diabetes mellitus due to underlying condition with diabetic autonomic polyneuropathy
E10.43	Type 1 diabetes mellitus with diabetic autonomic polyneuropathy
E11.43	Type 2 diabetes mellitus with diabetic autonomic polyneuropathy
E13.43	Other specified diabetes mellitus with diabetic autonomic polyneuropathy
K50.011	Crohn's disease of small intestine with rectal bleeding
K50.012	Crohn's disease of small intestine with intestinal obstruction
K50.013	Crohn's disease of small intestine with fistula
K50.018	Crohn's disease of small intestine with other complication
K50.111	Crohn's disease of large intestine with rectal bleeding
K50.112	Crohn's disease of large intestine with intestinal obstruction

1–10 of 75

1/8

CPT and deleted laboratory codes referenced in revision historyCPT

87506	CPT code moved from Table 1 to Table 2
0097U	Deleted code removed from the policy

Removed codeCPT

0097U

Deleted code removed from the policy

Reclassified codeCPT

87506

Code moved from Table 1 to Table 2

Place of ServiceModifier

19	Place of Service Code 19 added to Table 3

Standard panel threshold

Panel typeStandard gastrointestinal pathogen panel

Target thresholdFive or fewer targets

Coverage conditionAll standard panel medical-necessity criteria must be met

Expanded panel threshold

Panel typeExpanded gastrointestinal pathogen panel

Provider and Documentation Actions

Note

Review Applicable Medicare Guidance

For Medicare members/enrollees, review all applicable Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Medicare Coverage Articles before applying this policy. Medicare guidance takes precedence where applicable; consult the CMS website for current requirements.

Review applicable Medicare coverage guidance before applying the policy criteria.
For Medicaid members/enrollees, state Medicaid coverage provisions take precedence when they conflict with this policy.

Documentation Required

Required Medical-Record Documentation

The medical record must clearly document the clinical basis for testing and why panel testing is necessary. Include the provider type or specialty and Place of Service.

Specific clinical indications for testing, such as clinical suspicion that a pathogen is causing the patient’s condition.
Specific reasons for performing panel testing.

Ordering and Performance Requirements

Documentation Required

Meet ordering and performance requirements

The medical record must identify the ordering provider type or specialty and the place of service. Testing must be performed according to the test’s intended use and validated intended population.

Identify the ordering provider type or specialty.
Identify the place of service.
Use the test only for its validated intended population and intended use.

Policy Background

Multiplex gastrointestinal pathogen nucleic acid amplification panels qualitatively detect nucleic acid from multiple pathogens in stool specimens, including bacterial organisms such as Clostridium difficile, Escherichia coli, and Shigella; viral organisms such as norovirus and rotavirus; and parasitic organisms such as Cryptosporidium and Giardia. These multipathogen assays can identify several bacterial, viral, and parasitic agents simultaneously and generally provide results more rapidly than many conventional testing methods, supporting evaluation of suspected gastroenteritis or infectious colitis.

Molecular testing may detect viable or nonviable organisms, organisms present at nonpathogenic levels, and mixed infections. Results therefore require interpretation in the context of the member’s clinical presentation and should be used to inform appropriate management decisions.

Definitions

Nucleic acid amplification testing (NAAT)

DefinitionTesting that uses microorganism DNA or RNA to directly identify specific bacteria, viruses, and/or protozoa

ApproachIdentifies organisms directly rather than relying on bacterial culture, individual real-time PCR, immunoassays, or microscopy

Agents identifiedBacterial, viral, and protozoal agents

Multipathogen NAAT / CIDT

DefinitionCulture-independent diagnostic testing using multiplex nucleic acid amplification to detect multiple pathogens simultaneously

Pathogens detectedViral, parasitic, and bacterial agents

Policy Summary

PayerCommunity Care Independent Practice Association

PolicyGastrointestinal Pathogen Nucleic Acid Detection Panel Testing

Policy CodePolicy CP.MP.209

Change TypeAnnual review revision

Effective DateN/A

Last ReviewMar 1, 2023

Next Review DateN/A

SourceLink

On This Page

The member/enrollee is seriously or critically ill, or at imminent risk of becoming seriously or critically ill, as a result of a presumed gastrointestinal infection, and is being treated in an appropriate critical care facility.

Diarrhea indication AND one of the following

The diarrheal illness is acute or persistent with signs or risk factors for severe disease, such as fever, bloody diarrhea, dysentery, dehydration, or severe abdominal pain, that may warrant hospitalization.
The diarrheal illness has not resolved after seven days, and the member/enrollee has not taken laxatives within 24 hours before the test.

Immunocompromised member

The member is immunocompromised, including because of HIV or AIDS, chemotherapy, biologic or other immunosuppressive medication, transplant-related immunosuppressive drugs, high-dose systemic corticosteroids, or an inherited immune-system disorder such as a congenital immunoglobulin deficiency.
Applicable indication
- The member has presumed active gastrointestinal infection or an infection-associated complication requiring identification of a causative organism for appropriate management, including an atypical clinical presentation.
- Testing is performed once as part of a pre-transplant evaluation, regardless of whether symptoms are present.
  The pre-transplant evaluation exception applies to immunocompromised members.

Gastrointestinal Pathogen Panel Testing with Table 2 CPT and Supporting ICD-10 Codes

Gastrointestinal pathogen nucleic acid detection panel testing is medically necessary when billed according to the applicable coding requirements.

Coding requirements

CPT code: The testing is billed with a CPT code listed in Table 2: 87506 or 87507.
Place of service: The claim uses an applicable place-of-service code for a Table 2 CPT code.
ICD-10 diagnosis support: The claim includes the listed ICD-10 diagnosis code or code combination supporting medical necessity for the Table 2 CPT code, as specified in Tables 4, 5, and 6.
The applicable diagnosis-code requirements in the tables must be met for the billed CPT code.

Target thresholdGreater than six targets

Additional requirementAll standard panel criteria must be met, plus at least one qualifying expanded-panel indication

Persistent diarrhea

ConditionPersistent diarrheal illness

DurationNot resolved after seven days

Related testing requirementFor expanded panel testing, the member must not have taken laxatives within 24 hours of the test

Laxative restriction

RestrictionNo laxatives within 24 hours of the test

Applies toExpanded panel testing for diarrheal illness that has not resolved after seven days

Clinical contextPersistent diarrhea is an additional qualifying indication when the standard panel criteria are also met

Provider type/specialty and Place of Service.

Denial Risk

Denial Risk: Standard Panel Criteria Not Met

Gastrointestinal pathogen panel testing of five or fewer targets is not medically necessary when any standard criterion is absent. Deny or do not approve the panel if the clinical indication, expected management impact, intended-use validation, need for panel testing, or minimum pathogen composition requirement is not established.

The member/enrollee does not have a qualifying infectious-disease indication: immunocompetent with presumed active infection or infection-associated complications requiring identification of the causative organism, or immunocompromised as defined by the policy.
Testing results are not expected to change clinical management in a manner supported by peer-reviewed literature to improve outcomes.
The test is not being used according to its intended use or in its intended, validated population.
Targeted testing would provide sufficient information for appropriate clinical management.
The panel does not include at least the minimum pathogens reasonably detectable by the test that are required for clinical decision making.

Denial Risk

Denial Risk: Expanded Panel Criteria Not Met

Expanded gastrointestinal pathogen panel testing of greater than six targets is not medically necessary unless all standard criteria in section I are met and at least one qualifying expanded-panel circumstance is documented. Deny or do not approve the expanded panel when neither the standard criteria nor an additional expanded-panel indication is present.

The member/enrollee is not immunocompromised and does not have severe established GI pathology requiring identification of an infectious cause to determine management; is not seriously or critically ill or at imminent risk from presumed GI infection while receiving care in an appropriate critical care facility; and does not meet a qualifying diarrhea indication.
The standard-panel requirements—including clinical indication, expected management impact, intended-use validation, appropriateness of panel versus targeted testing, minimum pathogen composition, and required medical-record documentation—are not met.
The expanded panel is not supported by documentation of the applicable underlying GI pathology, critical illness/appropriate critical-care setting, or qualifying diarrheal illness.

Denial Risk

Denial Risk: Persistent Diarrhea Requirements Not Met

For the persistent-diarrhea expanded-panel pathway, the diarrheal illness must not have resolved after seven days, and the member/enrollee must not have taken laxatives within 24 hours before testing. If either requirement is not met, this pathway does not support medical necessity.

Deny under this persistent-diarrhea criterion when the illness has resolved within seven days or has not persisted beyond seven days.
Deny under this criterion when the member/enrollee took laxatives within 24 hours of the test.
This criterion does not replace the separate expanded-panel pathway for acute or persistent diarrhea with signs or risk factors for severe disease, such as fever, bloody diarrhea, dysentery, dehydration, severe abdominal pain, or potential need for hospitalization.

Relationship to CIDT

Multiplex NAAT is included within the larger grouping of culture-independent diagnostic tests

Immunocompromised

DefinitionA person with a weakened immune system

Included conditionsHuman immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS), and inherited diseases affecting the immune system such as congenital immunoglobulin deficiencies

Relevant treatmentsChemotherapy, biologics, transplant-related immunosuppressive drugs, or high-dose systemic corticosteroids

Testing considerationAtypical clinical presentations are considered appropriate indications for testing; testing may be performed once for a pre-transplant evaluation regardless of symptoms