Procedure Codes Description


Group 1 Codes:

0001M Infectious dis hcv 6 assays
0002M Liver dis 10 assays w/ash
0003M Liver dis 10 assays w/nash
0004M Scoliosis dna alys
0006M Onc hep gene risk classifier
0007M Onc gastro 51 gene nomogram
0008M Onc breast risk score
0009M Fetal aneuploidy trisom risk
0010M Onc prostate prob score
81161 – 81479 Dmd dup/delet analysis – Unlisted molecular pathology
81599 Unlisted maaa
84999 Clinical chemistry test
85999 Hematology procedure
86849 Immunology procedure
87999 Microbiology procedure
88199 Cytopathology procedure
88299 Cytogenetic study
88380 Microdissection laser
88381 Microdissection manual
88399 Surgical pathology procedure
89398 Unlisted reprod med lab proc
G0452 Molecular pathology interpr

Coverage Indications, Limitations, and/or Medical Necessity

This coverage policy provides the following information:

• defines tests required to register for a unique identifier
• defines tests required to submit a complete technical assessment (TA) for coverage determination
• defines the payment rules applied to covered tests that are not reported with specific CPT codes
• lists some examples of specific covered tests that have completed the registration and TA process and meet Medicare’s reasonable and necessary criteria for coverage. This listing is not inclusive.

Tests evaluated through the application process and/or technical assessment will be reviewed to answer the following questions:

• Is the test performed in the absence of clinical signs and symptoms of disease?
• Will the test results provide the clinician with information that will improve patient outcomes and/or change physician care and treatment of the patient?
• Will the test results confirm a diagnosis or known information?
• Is the test performed to determine risk for developing a disease or condition?
• Will risk assessment change management of the patient?
• Is there a diagnosis specific indication to perform the test?
• Is the test performed to measure the quality of a process or for Quality Control/Quality Assurance (QC/QA), i.e., a test to ensure a tissue specimen matches the patient?

MDT Policy Specific Definitions

MDT: Any test that involves the detection or identification of nucleic acid(s) (DNA/RNA), proteins, chromosomes, enzymes, cancer chemotherapy sensitivity and/or other metabolite(s). The test may or may not include multiple components. A MDT may consist of a single mutation analysis/identification, and/or may or may not rely upon an algorithm or other form of data evaluation/derivation.

LDT: Any test developed by a laboratory developed without FDA approval or clearance.

Applicable Tests/Assays

In addition to the MDT definition, this coverage policy applies to all tests that meet at least one of the following descriptions:
• All non-FDA approved/cleared laboratory developed tests (LDT)
• All modified FDA-approved/cleared kits/tests/assays
• All tests/assays billed with more than one CPT code to identify the service, including combinations of method-based, serology-based, and anatomic pathology codes
• All tests that meet the first three bullets and are billed with an NOC code

All Unlisted Anesthesia Codes / All Unlisted Surgical Procedures / All Unlisted Laboratory Procedures

For example: CPT 01999-Unlisted anesthesia procedure or CPT 19499-Unlisted procedure, breast or

 CPT 84999-Unlisted chemistry procedure

 Submit complete description of the procedure including operative report.

All Unlisted Radiology/Imaging Procedures

 For example: CPT 78799-Unlisted genitourinary procedure, diagnostic nuclear medicine

 Submit complete description of the procedure including imaging report

Molecular Diagnostic Tests (MDTs) Article Updates

Several changes have been made to the coverage articles below, primarily to the correct codes for reporting these services. In most cases, the articles were updated to refer to unlisted CPT code 81479 (unlisted molecular procedure) instead of CPT code 84999 (unlisted chemistry procedure). There are a few tests that have a specific CPT code for dates of service on or after 10/1/2014, instead of the unlisted CPT code.

A53191 MoPath: Afirma™ Assay by Veracyte Update-as of 10/01/2014 use CPT code 81479 instead of CPT code 84999
A53194 MoPath: bioTheranostics Cancer TYPE ID® Update- as of 10/01/2014 use CPT code 81479 instead of CPT code 84999
A53612 MoPath: ThxID™ BRAF V600/K Test Coding and Billing Guidelines-as of 10/01/2014 use CPT code
81210 instead of CPT code 84999
A53195 MoPath: cobas® 4800 BRAF V600 Test Billing/Coding Guidelines- as of 10/01/2014 use CPT code
81210 instead of CPT code 84999
A53205 MoPath: Vectra™ DA Coding and Billing Guidelines- as of 10/01/2014 use CPT code 81479 instead of CPT code 84999
A53204 MoPath:therascreen® KRAS PCR Kit Billing/Coding Guidelines-use CPT code 81275 as of 10/01/2014 instead of CPT code 84999 A53197 MoPath: Corus® CAD Test Coding and Billing Guidelines – as of 10/01/2014 use CPT 81479 instead of CPT code 84999
A53198 MoPath: HERmark® Assay by Monogram Update – as of 10/01/2014 use CPT code 81479 instead of CPT code 84999
A53200 MoPath: Oncotype DX® Breast Cancer Assay Billing and Coding Guidelines –use CPT code 81519 as of 01/01/2015 instead of CPT code 84999
A53201 MoPath: Oncotype DX® Colon Cancer Coding and Billing Guidelines -as of 10/01/2014 use CPT code
81479 instead of CPT code 84999
A53202 MoPath: Progensa® PCA3 Assay Coverage Update – as of 10/01/2014 use CPT code 81479 instead of CPT code 84999
A53248 MoPath: ResponseDX Tissue of Origin® Test-use CPT code 81504 as of 01/01/2015 instead of CPT code 84999

Unique Test Identifier Requirement

Because the available language in the HCPCS and CPT manuals to describe the pathology and laboratory categories and the tests included in those categories are not specific to the actual test results provided, all MDT services must include an identifier as additional claim documentation. Test providers must apply for an identifier specific to the applicable test and submit the test assigned identifier with the claim for reimbursement. The assigned identifier will provide a crosswalk between the test’s associated detail information on file and the submitted claim detail line(s) required to adjudicate each test’s claim. The unique identifier limits the need to submit the required additional information about the test on each claim.

Laboratory providers who bill MDT services must register services on the McKesson Diagnostics ExchangeTM.

Technology Assessments (TA)

MolDX will review all new test/assay clinical information to determine if a test meets Medicare’s reasonable and necessary requirement. Labs must submit a comprehensive dossier on each new test/assay prior to claim submission. MolDX will only cover and reimburse tests that demonstrate analytical and clinical validity, and clinical utility at a level that meets the Medicare reasonable and necessary requirement.

Payment Rules

MolDX will reimburse:

• approved tests covered for dates of service consistent with the effective date of the coverage determination.

Covered Tests

Please refer to the Noridian website for covered and excluded tests’ specific coding and billing information.

The following tests have completed the MolDX Program application review and/or technical assessment and meet Medicare reasonable and necessary criteria:

• Afirma™
• Allomap
• Avise PG
• Cancer TYPE ID
• cobas® 4800 BRAF V600
• cobas® EGFR
• ConfirmMDx Epigenetic Molecular Assay
• Corus® CAD
• HERmark®
• MammaPrint™
• Oncotype DX® Breast
• Oncotype DX® Colon
• Progensa® PCA3
• therascreen EGFR
• therascreen KRAS
• Tissue of Origin
• THXID™BRAF V600E/K Test
• Vectra™ DA
• Vysis

Other tests/assays may be covered by separate Noridian policy. In addition the CPT codes listed under Group 1 are covered. If a test is not listed, it may be covered under separate Noridian policy or it has not been approved for coverage as it has either not been vetted by the MolDx contractor or has been found to be considered statutorily excluded. A list of approved and excluded tests may be found on the Noridian webpage.

To obtain a unique identifier for a test and, to submit information for a technical assessment go to McKesson Diagnostics ExchangeTM:https://app.mckesson.com/#login.

For additional MolDX Program information, go to the Noridian Medicare home page at noridianmedicare.com and select MolDX under the Policies Tab.

MolDX expects laboratory providers to follow test indications published by the developer.

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
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Revenue Codes:
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

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