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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 say that UM is a rare cancer, affecting ~1600-1700 patients per year in the United States, but it is the 
most common intra-ocular cancer in adults. UM arises in the middle layer of the eye, the uvea tract, which 
consists of the iris, ciliary body, and choroid. Eye-sparing radiation (brachytherapy or proton beam therapy) is 
the most common treatment approach, but approximately 10% of patients will undergo enucleation due to large 
and/or aggressive tumors that cannot be managed with radiation or due to eye pain or vision loss. Local 
treatment by radiation or enucleation is highly successful at controlling the primary tumor, with only ~5% 
chance of local recurrence. Most patients present with local disease and no evidence of metastases, however, as 
many as 50% of patients will ultimately experience distant metastasis, most commonly to the liver. 
 
Clinicopathologic staging cannot reliably identify patients at low or high risk of metastasis, as even early stage 
patients (AJCC Stage I-II) have a substantial risk of metastasis and mortality. Historically, most UM patients 
were managed with high intensity surveillance, including frequent imaging and laboratory tests, with the goal 
of diagnosing early metastasis. Systematic imaging has been shown to be effective at identifying asymptomatic 
metastases, which is important because treatment of liver metastases with surgical resection or regional therapy 
is more effective and achieves better outcomes when tumor burden is low. However, since approximately 50% 
of patients will not experience metastasis, a substantial proportion of patients were subjected to unnecessary 
imaging, laboratory tests, and clinical visits, resulting in patient burden, undo exposure to radiation and over-
utilization of healthcare resources. 
 
An accurate determination of metastatic risk at diagnosis allows for a risk-appropriate surveillance program. 
Patients at high-risk of metastasis can continue to be followed with a high intensity program as previously 
prescribed, such as quarterly ultrasound, magnetic resonance imaging (MRI) or computerized tomography (CT) 
scans alternating with liver function tests (LFTs), and consideration of adjuvant treatment. These patients 
benefit from early detection of metastatic disease when it can be most effectively treated. Patients with low 
metastatic risk can be removed from this traditional intensive surveillance and instead followed with a low 
intensity program, such as yearly exams, imaging, and LFTs. 
 
 
 DecisionDx-UM is a ribonucleic acid (RNA) gene expression classifier that is based on the expression levels of 
15 mRNA transcripts (3 control and 12 discriminating genes). DecisionDx-UM is performed on tissue from a 
fresh-frozen fine needle aspirate biopsy (FNAB), formalin-fixed paraffin embedded (FFPE) sections from an 
enucleated tumor, or, in rare cases, fresh-frozen resection material. Results are reported as a 5-year risk 
classification for metastasis: low-risk (Class 1A), intermediate risk (Class 1B), or high risk (Class 2). 
 
The DecisionDx-UM test is intended for determination of metastatic risk, and to guide surveillance and referral 
to medical oncology in patients who have a confirmed diagnosis of UM and no evidence of metastatic disease. 
The test discriminates patients with high risk (class 2) for early distal recurrent disease from those with 
minimal risk of distal metastasis (class 1A). Identification of high-risk patients allows early referral to a 
medical oncologist with expertise in the management of UMs, which includes intensified metastatic 
surveillance and/or metastasis intervention, and stratification for entry into clinical trials with adjuvant therapy. 
In rare cases where the patient cannot realistically see a medical oncologist due to geographic location (long 
distance to travel), and/or are among underserved patient populations, if they cannot feasibly see a medical 
oncologist, surveillance testing for class 2 patients can be directed by an ophthalmologist with specific training 
in treating patients with UM. You can find this rule in the Local Coverage Determination (LCD) 
MolDX: Decision Dx-UM (Uveal Melanoma) L37210. 
 
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.