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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case.
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101.
The rules say that for next generation sequencing (NGS) the nationally covered indications are as follows:
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: Patient has either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer; and not
been previously tested with the same test using NGS for the same cancer genetic content, and decided to seek
further cancer treatment (e.g., therapeutic chemotherapy). The diagnostic laboratory test using NGS must have
Food & Drug Administration (FDA) approval or clearance as a companion in vitro diagnostic; and, an FDAapproved
or -cleared indication for use in that patient's cancer; and, 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: Patient has ovarian or breast cancer; and, a clinical indication for germline
(inherited) testing for hereditary breast or ovarian cancer; and, a risk factor for germline (inherited) breast or
ovarian cancer; and not been previously tested with the same germline test using NGS for the same germline
genetic content. The diagnostic laboratory test using NGS must have all of the following: FDA-approval or
clearance; and results provided to the treating physician for management of the patient using a report template
to specify treatment options.
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: either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; and, not been
previously tested with the same test using NGS for the same cancer genetic content, and 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: any cancer diagnosis; and, a clinical
indication for germline (inherited) testing of hereditary cancers; and, a risk factor for germline (inherited)
cancer; and, not been previously tested with the same germline test using NGS for the same germline genetic
content. (This NCD last reviewed January 2020). You can find this rule in the Medicare National Coverage
Determination (NCD) Next Generation Sequencing (NGS) 90.2.
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.