Appeal type: unknown
Decision: unknown

Please note, the Local Coverage Article (LCA A55624) the Plan used to deny services is not binding in this 
case. The LCA does not have Part B jurisdiction where the services were provided.  
 
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 screening tests are excluded from coverage. The only exceptions are for the following 
services: 
 
1. screening mammography,  
2. colorectal cancer screening tests, 
3. screening pelvic exams,  
4. prostate cancer screening tests,  
5. glaucoma screening exams,  
6. ultrasound screening for abdominal aortic aneurysms (AAA),  
7. cardiovascular disease screening tests,  
8. diabetes screening tests, and 
9. screening electrocardiograms 
10. certain other testing recommended by the United States Preventive Services Task Force and approved by 
CMS 
You can find this rule at 42 CFR Section 411.15(a)(1) and 42 CFR Section 410.64. 
 
The rules say 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. 
 
2.    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 this rule in the Medicare National Coverage Determination for 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.