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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. 
 
The rules state that MolDX will reimburse: 
approved tests covered for dates of service consistent with the effective date of the coverage determination. 
 
You can find this rule in the Local Coverage Determination (LCD) for MolDX: Molecular Diagnostic Tests 
(MDT), L36807. 
 
The rules say that for laboratories performing single gene technologies, a sequential genetic testing approach is 
expected. Once a positive result is obtained and the appropriate diagnosis is established, further testing should 
stop. Reflex testing to the next gene will be considered reasonable and necessary if the following sequence of 
genetic tests produce a negative result: 
1. BCR-ABL negative test results, progress to #2 
2. JAK 2, cv negative test results, progress to #3 or #4 
3. JAK, exon 12 (JAK2 exon 12 is only done when PV is suspected) 
4. Calreticulin (CALR)/MPL (CALR/MPL is only done when either ET or PMF is suspected; testing for 
CALR/MPL does NOT require a negative JAK2 exon 12, just a negative JAK2 V617F result) 
Genetic testing of the JAK2 V617F mutation is medically necessary when the following criteria are met: 
A. Genetic testing impacts medical management; and  
B. Patient would meet World Health Organizations (WHO) diagnostic criteria for myeloproliferative 
disease (i.e., PV, ET, PMF) if JAK2 V617F were identified. 
Genetic testing of JAK2 exon 12, performed to identify PV, is medically necessary when the following criteria 
are met: 
A. Genetic testing impacts medical management; and 
B. Patient would meet WHOs diagnostic criteria for PV, if JAK2 exon 12 testing were positive; and 
C. JAK2 V617F mutation analysis was previously completed and was negative. Genetic testing of the CALR gene (only found in ET and PMF) is medically necessary when the following 
criteria are met: 
A. Genetic testing impacts medical management; and 
B. JAK2 V617F mutation analysis was previously completed and negative; and 
C. Patient would meet WHOs diagnostic criteria for MPD (i.e. ET, PMF) if a clonal marker were 
identified. 
Genetic testing of the MPL gene is medically necessary when the following criteria are met: 
A. Genetic testing impacts medical management; and 
B. JAK2 V617F mutation analysis was previously completed and negative; and 
C. Patient would meet WHOs diagnostic criteria for MPD (i.e., ET, PMF) if a clonal marker were 
identified. 
Note: In a single-gene sequential approach (not mandated by this policy), CALR would be a higher priority 
single gene test than MPL because: 
A. CALR mutations is more prevalent than MPL mutations in ET/PMF patients; and  
B. CALR mutations are reported to predict a more indolent disease course than that of patients with JAK2 
mutations. 
For laboratories performing NGS or "hotspot" testing platforms: Molecular testing for BCR-ABL, JAK 2, JAK, 
exon 12, and CALR/MPL genes by NGS is covered as medically necessary for the identification of 
myeloproliferative disorders. 
You can find these rules in the Local Coverage Determination (LCD) for MolDX: Genetic Testing for BCR-
ABL Negative Myeloproliferative Disease, L36815. 
 
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.