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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 state that lung cancer is the leading cause of cancer deaths in the United States. New screening 
programs are expected to save lives through early detection but are also expected to increase the number of 
patients who undergo invasive procedures to evaluate suspicious lung nodules and lesions. Traditionally, 
following the identification of a suspicious lung nodule or lesion, clinical characteristics are utilized to 
determine risk and to determine whether patients should proceed to an invasive biopsy. Clinical characteristics 
that have statistically correlated with a higher risk of malignancy in risk assessment models include older age, 
smoking history, nodule size and spiculation. Anatomic location, solid versus part-solid or non-solid 
characteristics, and time since smoking discontinuation have had less consistent correlation. However, variation 
in cohort demographics and data availability used in developing these models, including prevalence of 
malignancy (3.7% to 54%), have challenged consistent utilization of these models when used alone in clinical 
practice. 
 
The American College of Chest Physicians (CHEST) published clinical guidelines in 2013 to assist clinicians 
with assigning risk allocation. 
Table 1: CHEST  Assessment of the probability of malignancy based on clinical factors alone. 
Probability of Malignancy 
Low (<5%) Intermediate (5-65%) High (>65%) 
Young, less smoking, no 
prior cancer, smaller nodule 
size, regular margins, 
and/or non-upper-lobe 
location 
Mixture of low and high 
probability features 
Older, heavy smoking, prior 
cancer, larger size, 
irregular/spiculated 
margins, and/or upper-lobe 
location 
  
At the current time, in the absence of definitive guidelines, patients assigned with a physician-assessed low or 
intermediate risk for malignancy may be considered for serial CT surveillance or invasive biopsy, and many of 
these patients ultimately undergo surgery for benign disease. Newer predictive models, which incorporate a 
number of radiological and clinical features to predict malignancies, may be more predictive than physician 
assessment alone in preventing invasive procedures in patients with benign nodules. Even with these risk 
models, supplementary methods to improve diagnostic accuracy are important to prevent unneeded morbidity, 
mortality and costs from invasive procedures, without increasing the risk of missing a malignancy. 
BRONCHOSCOPY is a non-surgical diagnostic method that enables physicians to visualize and collect cells 
from the patients lung airways. An estimated 250,000 patients undergo BRONCHOSCOPY each year in the 
United States to evaluate lung nodules that are suspicious for cancer.
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 Up to 40% of BRONCHOSCOPY procedures result in a non-diagnostic outcome, which means the clinician could not 
reach a clinically actionable benign or malignant diagnosis. Physicians are then faced with the dilemma of 
whether to monitor these patients with CT surveillance or proceed to a surgical lung biopsy or transthoracic 
needle biopsy associated with a greater risk of morbidity, such as pneumothorax or hemorrhage, or mortality. 
You can find this rule at the Medicare Local Coverage Determination (LCD)- L37195, MolDX: Percepta 
Bronchial Genomic Classifier. 
 
The rules say that medically necessary services are those that are reasonable and necessary for the diagnosis or 
treatment of an illness or injury. Medically necessary services include services to improve the functioning of a 
malformed body member. You can find this rule in the Social Security Act, Section 1862(a)(1)(A). 
 
The rules say that services that are not medically necessary are not covered. The rules also say that 
experimental and investigational devices are not covered. You can find this rule at 42 CFR Sections 411.15 and 
411.15(o). 
 
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.