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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 state that the following are indications for Next Generation Sequencing (NGS):
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:
i. either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer; and
ii. not been previously tested with the same test using NGS for the same cancer genetic content, and
iii. decided to seek further cancer treatment (e.g., therapeutic chemotherapy).
b. The diagnostic laboratory test using NGS must have:
i. Food & Drug Administration (FDA) approval or clearance as a companion in vitro diagnostic; and,
ii. an FDA-approved or -cleared indication for use in that patient's cancer; and,
iii. 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:
i. ovarian or breast cancer; and,
ii. a clinical indication for germline (inherited) testing for hereditary breast or ovarian cancer; and,
iii. a risk factor for germline (inherited) breast or ovarian cancer; and
iv. 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:
i. FDA-approval or clearance; and,
ii. results provided to the treating physician for management of the patient using a report template to specify treatment options.

You can find these rules in the Medicare National Coverage Determination (NCD) for Next Generation Sequencing (NGS), Section 90.2.

The rules state that molecular pathology procedures (Tier1 and Tier 2) may be eligible for coverage when ALL of the following criteria are met:

- Alternative laboratory or clinical tests to definitively diagnose the disorder/identify the condition are unavailable or results are clearly equivocal; AND
- Availability of a clinically valid test, based on published peer reviewed medical literature; AND
- Testing assay(s) are Food and Drug Administration (FDA) approved/cleared or if LDT (lab developed test) or LDT protocol or FDA modified test(s) the laboratory documentation should support assay(s) of analytical validity and clinical utility; AND
- Results of the testing must directly impact treatment or management of the Medicare beneficiary; AND
- For testing panels, including but not limited to, multiple genes or multiple conditions, and in cases where a tiered approach/method is clinically available, testing would be covered ONLY for the number of genes or test that are reasonable and necessary to obtain necessary information for therapeutic decision making; AND
- Individual has not previously received genetic testing for the disease/condition. (In general, diagnostic genetic testing for a disease should be performed once in a lifetime.) Exceptions include clinical scenarios whereby repeat testing of somatically-acquired mutations (for example, pre- and post- therapy) may be required to inform appropriate therapeutic decision-making.

You can find these rules in the Local Coverage Determination (LCD) for Molecular Pathology Procedures, L35000. This LCD is effective for services provided on or after July 1, 2020.

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.