Billing and Coding: Biomarkers for Oncology

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) L35396, Biomarkers for Oncology. Please refer to
the LCD for reasonable and necessary requirements.  
  
 **Coding Guidance**  
  
 **Notice:** It is not appropriate to bill Medicare for services that are not
covered (as described by the entire LCD) as if they are covered. When billing
for non-covered services, use the appropriate modifier.

**Test Panel Definition**

A predetermined set of medical tests composed of individual laboratory tests
related by medical condition, specimen type, frequency ordered, methodology or
types of components to aid in the diagnosis/treatment of diseases. The
performance of multiple molecular tests regardless of whether the requisition
lists the tests as a panel or individually and completed on a single sample is
considered to be a Panel of tests and should be billed under a single CPT code
to prevent stacking of codes.

Consistent with the Limitations outlined in LCD, Biomarkers for Oncology, the
following tests will all be covered once per lifetime per beneficiary:

  * CPT code 81345 - Brain Molecular Biomarkers
  * CPT code 81437 - Hereditary neuroendocrine tumor disorders
  * CPT code 81438 - Hereditary neuroendocrine tumor disorders; duplication/deletion analysis
  * ThyraMIR (CPT 0018U), Afirma (CPT 81546), ThyGeNEXT (CPT 0245U), RosettaGX Reveal (CPT 81479) and ThyroSeq tests (CPT 0026U) (CPT 0287U) 
    * Should the unlikely situation of a second, unrelated thyroid nodule with indeterminate pathology occur, coverage may be considered upon appeal with supporting documentation
  * CPT code 81540 TUO CTID (Cancer TYPE ID)

  
**Review of General Molecular Pathology Coding Changes  **

In 2012, CPT created new Tier 1 (gene specific) and Tier 2 molecular pathology
codes.

The Tier 1 molecular pathology codes are applicable to specific biomarkers.
However, Tier 2 molecular pathology codes are used to identify groups of
biomarkers that require the similar levels of technical and interpretive
resources required to complete the testing. Tier 2 codes represent rare
disease and molecular pathology procedures that are performed in lower volumes
than Tier 1 procedures. These codes should rarely, if ever, be used unless
instructed by other coding and billing articles.

Because there are multiple biomarkers represented by each of the Tier 2 codes,
when billing for these codes, the specific biomarker must be reported in the
claim narrative/remarks.

Reporting of the specific biomarker, WITHOUT providing the full descriptor
will suffice. However, in some cases, such as the example provided below, it
may be necessary to provide abbreviated information to identify the specific
service provided.

CPT code 81479 - Unlisted molecular pathology should be used to report a
specific biomarker that is not represented by a Tier 1 code and is not
accurately described by one of the Tier 2 codes.

  * A description of the testing performed must be included in the narrative/remarks when using this code.

**Billing Claims with Multiple Biomarkers**

Please refer to the Local Coverage Article A58917, Billing and Coding:
Molecular Pathology and Genetic Testing for information.

**Selected Oncology Tests**

1\. UroVysion Bladder Kit services

The following information should be reported on the claim:

  * CPT code 88120 or 88121 as appropriate.
  * 'UroVysion' should be placed in the comment/narrative field for the following claim field/types:   

    * Loop 2400, NTE02, or SV101-7 for the 5010A1 837P
  * Submit 'UroVysion' on an attachment to the claim form when submitting a paper claim.

Laboratories reporting only the technical component for a UroVysion service
should append the appropriate CPT code 88120 or 88121 with the TC HCPCS
modifier.

**Note:** Physicians may not submit claims for a CPT code 88120 and 88121
professional component when the interpretive information is provided by a lab
technician or scientist. Please refer to CMS IOM 100-04, Chapter 23, Section
20.9 for National Correct Coding Initiative (NCCI) information.  
  
2\. Rosetta Cancer Origin TestTM when a conventional surgical pathology/imaging
work-up is unable to identify a primary neoplastic site.

The following information should be reported on the claim:

  * CPT code 81479 Unlisted molecular pathology procedure
  * Enter 'Initial Work-Up ...' in the comment/narrative field for the following claim field/types:   

    * Loop 2400, NTE02, or SV101-7 for the 5010A1 837P
  * Submit 'Initial Work-Up ...' on an attachment to the claim form when submitting a paper claim.

**Note:** The full, continued version of this Initial Work-Up comment DOES NOT
have to be a standardized response, but simply a brief summary (totaling less
than 80 characters) to ensure that a preliminary surgical pathology evaluation
has been performed prior to the ordering of the biomarker. An example might
read as follows: 'Initial Work-Up shows medium probability of breast CA via
IHC'.

3\. VeriStrat assay (CPT code 81538)

  * Enter 'Initial Work-Up ...' in the comment/narrative field for the following claim field/types:   

    * Loop 2400, NTE02, or SV101-7 for the 5010A1 837P
  * Submit 'Initial Work-Up ...' on an attachment to the claim form when submitting a paper claim.

**Note:** The full, continued version of this Initial Work-Up comment DOES NOT
have to be a standardized response, but simply a brief summary (totaling less
than 80 characters) to ensure that a preliminary predictive testing evaluation
has been performed prior to the ordering of the VeriStrat assay. Two examples
might read as follows:

  * 'Initial Work-Up shows EGFR wild-type'
  * 'Initial Work-Up without ability to test EGFR'

4\. OVA1TM and ROMATM proteomic assays  
  
OVA1 has been cleared by the FDA for women who meet all of the following
criteria:

  * Are over 18 years of age
  * Have an ovarian mass
  * Have surgery planned

Enter 'The patient meets all 3 FDA OVA1 criteria' in the comment/narrative
field for the following claim field/types:

  * Loop 2400, NTE02, or SV101-7 for the 5010A1 837P

Submit 'The patient meets all 3 FDA OVA1 criteria' on an attachment to the
claim form when submitting a paper claim.  
  
For OVA1TM, use CPT code 81503.

5\. PROGENSA PCA3 test (regarding prostate cancer):

  * Should be billed with CPT code 81313
  * Claim must include PCA3 and contain one of the corresponding ICD-10-CM codes listed in the ICD-10-CM Codes that Support Medical Necessity Group 9 below.

6\. MyPRS Genetic Expression Profile Testing

  * Should be billed with CPT code 81479
  * 'MyPRS' should be entered in box 19, or electronic equivalent, on the claim
  * Claim must include one of the corresponding ICD-10-CM codes listed in the ICD-10-CM Codes that Support Medical Necessity Group 24 below.

7\. ThyraMIR, ThyGeNEXT, Afirma, RosettaGX Reveal or ThyroSeq Thyroid  
  
**Intended use of ThyraMIR**

ThyraMIR may be used for cytologically indeterminate thyroid nodules
categorized as either AUS/FLUS or FN/SFN within the Bethesda classification
scheme for FNA cytology. It is performed following a negative ThyGeNEXT result
for all mutations or when mutations detected are not fully indicative of
malignancy (i.e., ThyGeNEXT results which favor a benign nodule, but cancer
could still be present). ThyGeNEXT, and ThyraMIR combination testing, along
with other clinical information, may be used by physicians to help determine
the need for surgery or clinical follow up when patients are diagnosed with
indeterminate thyroid nodules.

The original FNA sample collected for molecular testing with ThyGeNEXT is also
used to perform the ThyraMIR test; a separate sample is not required.

To report a ThyraMIR service, please submit the following claim information:

  * CPT code 0018U
  * Enter ThyraMIR in the comment/narrative field for the following claim field/types: 
    * Part A claims: 
      * Loop SV202-7 for 837I electronic claim
      * Block 80 for the UB04 claim form
    * Part B claims: 
      * Loop 2400 or SV101-7 for the 5010A1 837P
      * Box 19 for the paper claim

To report ThyGeNEXT tests, please submit the following claim information:

  * CPT code 0245U
  * Enter ThyGeNEXT in the comment/narrative field 
    * Part A claims: 
      * Loop SV202-7 for 837I electronic claim
      * Block 80 for the UB04 claim form
    * Part B claims: 
      * Loop 2400 or SV101-7 for the 5010A1 837P
      * Box 19 for the paper claim

To report Afirma tests, please submit the following claim information:

  * CPT code 81546
  * Enter Afirma in the comment/narrative field 
    * Part A claims: 
      * Loop SV202-7 for 837I electronic claim
      * Block 80 for the UB04 claim form
    * Part B claims: 
      * Loop 2400 or SV101-7 for the 5010A1 837P
      * Box 19 for the paper claim

To report RosettaGX Reveal Thyroid tests, please submit the following claim
information:

  * CPT code 81479
  * Enter Rosetta GX Reveal Thyroid in the comment/narrative field 
    * Part A claims: 
      * Loop SV202-7 for 837I electronic claim
      * Block 80 for the UB04 claim form
    * Part B claims: 
      * Loop 2400 or SV101-7 for the 5010A1 837P
      * Box 19 for the paper claim

To report ThyroSeq Thyroid tests, please submit the following claim
information:

  * CPT code 0026U or 0287U
  * Enter ThyroSeq test in the comment/narrative field 
    * Part A claims: 
      * Loop SV202-7 for 837I electronic claim
      * Block 80 for the UB04 claim form
    * Part B claims: 
      * Loop 2400 or SV101-7 for the 5010A1 837P
      * Box 19 for the paper claim

Please refer to LCD L35396-Biomarkers for Oncology for coverage details for
ThyraMIR, Afirma, ThyGeNEXT, RosettaGX Reveal and ThyroSeq Thyroid tests.

8\. Oncomine DX Test

To report Oncomine DX Test service, please submit the following claim
information:

  * CPT code 0022U - Tgt gen seq dna&rna 1-23 gene
  * The identifier of 'Oncomine DX' must be in the comment/narrative field as follows:
  *     * Part A claims: 
      * Loop SV202-7 for 837I electronic claim
      * Block 80 for the UB04 claim form
    * Part B claims: 
      * Loop 2400 or SV101-7 for the 5010A1 837P
      * Box 19 for the paper claim

9\. ColonSeq test

  * Should be billed with CPT code 81445
  * Enter ColonSeq in the comment/narrative field for the following claim field/types.
    * Part A claims: 
      * Loop SV202-7 for 837I electronic claim
      * Block 80 for the UB04 claim form
    * Part B claims:
      * Loop 2400 or SV101-7 for the 5010A1 837P
      * Box 19 for the paper claim
  * The claim must contain one of the corresponding ICD-10-CM codes listed in the ICD-10-CM Codes that Support Medical Necessity Group 1 below.

10\. LungSeq test

  * Should be billed with CPT code 81445
  * Enter LungSeq in the comment/narrative field for the following claim field/types.
    * Part A claims: 
      * Loop SV202-7 for 837I electronic claim
      * Block 80 for the UB04 claim form
    * Part B claims:
      * Loop 2400 or SV101-7 for the 5010A1 837P
      * Box 19 for the paper claim
  * The claim must contain one of the corresponding ICD-10-CM codes listed in the ICD-10-CM Codes that Support Medical Necessity Group 2 below.

11\. Colvera test (BCAT1/IKZF1 promoter hypermethylation)

**Intended use of Colvera**  

Colvera is a diagnostic laboratory test used to detect the presence of
colorectal cancer circulating tumor DNA. Colvera is intended to be used to
detect residual disease following surgery or treatment for primary or
recurrent colorectal cancer, and to surveil for recurrence of a previously
treated colorectal cancer. Testing is covered when all the following are met:

  1.     1. The patient has been previously diagnosed with an AJCC stage I, II, III or IV colorectal cancer, or a recurrence of colorectal cancer, within the previous five years.
    2. The patient has no evidence of neoplastic disease at the time the test is ordered. (If the patient is known to be with cancer or presumed to have cancer, this testing is not indicated).
    3. The patient is able to tolerate surgery or adjuvant chemotherapy for residual or recurrent colorectal cancer.
    4. Testing may be ordered no more than four times per 12-month period.

To report a Colvera service, please submit the following claim information:

  * CPT code 0229U
  * Enter Colvera in the comment/narrative field for the following claim/field types:
  *     * Part A claims: 
      * Loop SV202-7 for 837I electronic claim
      * Block 80 for the UB04 claim form
    * Part B claims: 
      * Loop 2400 or SV101-7 for the 5010A1 837P
      * Box 19 for the paper claim
  * The claim must contain one of the corresponding ICD-10-CM codes listed in the ICD-10-CM Codes that Support Medical Necessity Group 1 below.

**Documentation Requirements**

  1. All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
  2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
  3. The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.
  4. The medical record documentation must support the medical necessity of the services as stated in the LCD. Specifically, the medical record should reflect whether any biomarker ordered is diagnostic, prognostic or predictive, as well as be able to clearly correlate any test result with given interventions **(e.g., particular selection of chemotherapy).**