Appeal type: unknown
Decision: unknown

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.

Medicare rules state that Lynch Syndrome (LS) tumor screening for DNA mismatch repair (MLH1, MSH2, MSH6 and PMS2) by qualitative IHC and/or microsatellite instability (MSI) is considered medically necessary and covered by Medicare for the following indications:
-All individuals with colorectal cancer diagnosed at age =70 years of age, and those > 70 years of age
who meet the revised Bethesda guidelines OR
-Individuals with endometrial cancer

No definitive algorithm for LS screening has been recommended. However, if IHC is done first and is abnormal, MSI testing is not warranted. If IHC is normal, MSI may be warranted. IHC testing LS is qualitative and does not require the use of tumor morphometry. Chemosensitivity profile tumor panels, regardless of whether it is performed by IHC or chromogenic in-situ hybridization (CISH), is not reasonable and necessary for the reasons cited above and is not a Medicare covered service. You can find these rules in Local Coverage Determination (LCD) Lab: Special Histochemical Stains and Immunochemical Stains (L36805).

Medicare rules state that - 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.
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 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.