License for Use of "Physicians' Current Procedural Terminology", (CPT) Fourth Edition

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POINT AND CLICK LICENSE FOR USE OF "CURRENT DENTAL TERMINOLOGY", ("CDT")

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IMPORTANT: THIS DOCUMENT CONTAINS OUTDATED INFORMATION.

Content provided on this page contains outdated information and instruction and should not be considered current. CGS is providing this archived information for research purposes only. This archived section contains previously issued instructions that have since been updated or are no longer applicable for Medicare billing purposes.

October 5, 2015 - Updated 02.01.17

MolDX:FDA Approved ALK Companion Diagnostic Tests Coding and Billing Guidelines (CM00022, V2)

To date, two tests have received FDA approval to detect rearrangements of the anaplastic lymphoma kinase (ALK) gene in non-small-cell lung cancer (NSCLC) (adenocarcinoma) and identify patients eligible for treatment with XALKORI® (crizotinib). XALKORI® is indicated for the treatment of patients with locally advanced or metastatic NSCLC that is ALK-positive as detected by these companion diagnostics.

Effective August 27, 2011

Vysis ALK Break Apart Fish Probe Kit by Abbot meets the reasonable and necessary criteria for Medicare reimbursement.
To report a Vysis kit service, please submit the following claim information:
- Select the CPT codes 88374 or 88377 for your service
- Enter 1 units of service (UOS)
- Enter the assigned DEX Z-Code ID in the comment/narrative field for the following claim field/types:
  - Loop 2300 NTE 01/SV202-7 for Part A or Loop 2400 or SV101-7 for the 5010A1 837P for Part B
  - Submit assigned DEX Z-Code ID on an attachment to the claim form for paper claim (Form locator 80 for Part A or Box 19 for Part B)

Effective June 12, 2015

Ventana ALK (D5F3) CDx Assay by Ventana Medical Systems, a laboratory immunohistochemical test meets the reasonable and necessary criteria for Medicare reimbursement.
To report a Ventana ALK service, please submit the following claim information:
- Enter CPT code 88342
- Enter the assigned DEX Z-Code ID in the comment/narrative field for the following claim field/types:
  - Loop 2300 NTE 01/SV202-7 for Part A or Loop 2400 or SV101-7 for the 5010A1 837P for Part B
  - Submit assigned DEX Z-Code ID on an attachment to the claim form for paper claim (Form locator 80 for Part A or Box 19 for Part B)

The following diagnoses sets are appropriate for both tests:

Select the appropriate ICD-9-CM code for DOS prior to 10/01/2015
- 162.2 – Malignant neoplasm of trachea, bronchus, and lung; main bronchus
- 162.3 – Malignant neoplasm of trachea, bronchus, and lung; upper lobe, bronchus or lung
- 162.4 – Malignant neoplasm of trachea, bronchus, and lung; middle lobe, bronchus or lung
- 162.5 – Malignant neoplasm of trachea, bronchus, and lung; lower lobe, bronchus or lung
- 162.8 – Malignant neoplasm of trachea, bronchus, and lung; other parts of bronchus or lung
- 162.9 – Malignant neoplasm of trachea, bronchus, and lung; bronchus and lung, unspecified
Select the appropriate ICD-10-CM code for DOS on and after 10/01/2015
- C34.01 – Malignant neoplasm of right main bronchus
- C34.02 – Malignant neoplasm of left main bronchus
- C34.11 – Malignant neoplasm of upper lobe, right bronchus or lung
- C34.12 – Malignant neoplasm of upper lobe, left bronchus or lung
- C34.2 – Malignant neoplasm of middle lobe, bronchus or lung
- C34.31 – Malignant neoplasm of lower lobe, right bronchus or lung
- C34.32 – Malignant neoplasm of lower lobe, left bronchus or lung
- C34.81 – Malignant neoplasm of overlapping sites of right bronchus and lung
- C34.82 – Malignant neoplasm of overlapping sites of left bronchus and lung
- C34.91 – Malignant neoplasm of unspecified part of right bronchus or lung
- C34.92 – Malignant neoplasm of unspecified part of left bronchus or lung

Additional Information:

To bill the professional component (PC), the pathologist must read and interpret the raw data. Per Chapter 10, Version 16.3 in the NCCI Policy Manual for Medicare Services, physicians may not report the PC provided by the technician or scientist. The pathologist must append the CPT code claim line with the assigned ID.

Note: This MolDX coverage determination and coding guideline ONLY applies to the UNMODIFIED, Vysis Kit by Abbot and Ventana ALK (D5F3) CDx for patients with non-small cell lung cancer. If a lab modifies these tests, a MolDX Technical Assessment, outlined in the MolDX section, must be submitted and a determination assessed prior to claims submission.

License for Use of "Physicians' Current Procedural Terminology", (CPT) Fourth Edition

AMA Disclaimer of Warranties and Liabilities.

CMS Disclaimer

POINT AND CLICK LICENSE FOR USE OF "CURRENT DENTAL TERMINOLOGY", ("CDT")

MolDX:FDA Approved ALK Companion Diagnostic Tests Coding and Billing Guidelines (CM00022, V2)

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