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. 
 
  
  The rules say that this policy provides coverage for multi-gene non-next generation sequencing (NGS) panel 
testing and NGS testing for the diagnostic workup for myeloproliferative disease (MPD), and limited coverage 
for single-gene testing of patients with BCR-ABL negative MPD. MPD includes polycythemia vera (PV), 
essential thrombocythemia (ET), and primary myelofibrosis (PMF). 
 
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: 
 
    BCR-ABL negative test results, progress to #2 
    JAK 2, cv negative test results, progress to #3 or #4 
    JAK, exon 12 (JAK2 exon 12 is only done when PV is suspected) 
    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: 
    Genetic testing impacts medical management; and 
    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: 
    Genetic testing impacts medical management; and 
    Patient would meet WHO's diagnostic criteria for PV, if JAK2 exon 12 testing were positive; and 
    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: 
 
    Genetic testing impacts medical management; and 
    JAK2 V617F mutation analysis was previously completed and negative; and 
    Patient would meet WHO's 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: 
 
    Genetic testing impacts medical management; and 
    JAK2 V617F mutation analysis was previously completed and negative; and 
    Patient would meet WHO's diagnostic criteria for MPD (i.e., ET, MPF) 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: 
 
    CALR mutations is more prevalent than MPL mutations in ET/PMF patients; and 
    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) MolDX: 
Genetic Testing for BCR-ABL Negative Myeloproliferative Disease L36044. 
 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.