**B.    Nationally Covered Indications

**

1\.     _Somatic (Acquired) Cancer_

Effective for services performed on or after March 16, 2018, the Centers for
Medicare & Medicaid Services (CMS) has determined that Next Generation
Sequencing (NGS) as a diagnostic laboratory test is reasonable and necessary
and covered nationally, when performed in a Clinical Laboratory Improvement
Amendments (CLIA)-certified laboratory, when ordered by a treating physician,
and when all of the following requirements are met:

   a. Patient has:  

  1. either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer; and
  2. not been previously tested with the same test using NGS for the same cancer genetic content, and
  3. decided to seek further cancer treatment (e.g., therapeutic chemotherapy).

   b. The diagnostic laboratory test using NGS must have:

  1. Food & Drug Administration (FDA) approval or clearance as a companion in vitro diagnostic; and,
  2. an FDA-approved or -cleared indication for use in that patients cancer; and,  

  3. results provided to the treating physician for management of the patient using a report template to specify treatment options.

2\.     _Germline (Inherited) Cancer_

Effective for services performed on or after January 27, 2020, CMS has
determined that NGS as a diagnostic laboratory test is reasonable and
necessary and covered nationally for patients with germline (inherited)
cancer, when performed in a CLIA-certified laboratory, when ordered by a
treating physician and when all of the following requirements are met:

   a. Patient has:  

  1. ovarian or breast cancer; and,
  2. a clinical indication for germline (inherited) testing for hereditary breast or ovarian cancer; and,
  3. a risk factor for germline (inherited) breast or ovarian cancer; and
  4. not been previously tested with the same germline test using NGS for the same germline genetic content.

   b. The diagnostic laboratory test using NGS must have all of the following:  

  1. FDA-approval or clearance; and,
  2. results provided to the treating physician for management of the patient using a report template to specify treatment options.

**C.    Nationally Non-Covered Indications**

1\. Somatic (Acquired) Cancer**

Effective for services performed on or after March 16, 2018, NGS as a
diagnostic laboratory test for patients with acquired (somatic) cancer are
non-covered if the cancer patient does not meet the criteria noted in section
B.1., above.

**D.    Other**

1\.     _Somatic (Acquired) Cancer_

Effective for services performed on or after March 16, 2018, Medicare
Administrative Contractors (MACs) may determine coverage of NGS as a
diagnostic laboratory test for patients with advanced cancer only when the
test is performed in a CLIA-certified laboratory, when ordered by a treating
physician, and when the patient has:

  1. either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; and,
  2. not been previously tested with the same test using NGS for the same cancer genetic content, and
  3. decided to seek further cancer treatment (e.g., therapeutic chemotherapy).

2\.     _Germline (Inherited) Cancer_

Effective for services performed on or after January 27, 2020, MACs may
determine coverage of NGS as a diagnostic laboratory test for patients with
germline (inherited) cancer only when the test is performed in a CLIA-
certified laboratory, when ordered by a treating physician, when results are
provided to the treating physician for management of the patient and when the
patient has:

  1. any cancer diagnosis; and,
  2. a clinical indication for germline (inherited) testing of hereditary cancers; and,
  3. a risk factor for germline (inherited) cancer; and,
  4. not been previously tested with the same germline test using NGS for the same germline genetic content.

(This NCD last reviewed January 2020)