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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 the clinical care of patients with breast cancer depends upon the accurate diagnosis and the 
assessment of biomarkers. Hormone receptor assays and Her2 testing are recommended on all primary invasive 
breast cancers, and on recurrent or metastatic cancers. At the current time, there is no recommendation for Her2 
testing on in situ breast lesions outside of a clinical trial. While there are a number of promising additional 
biomarkers, such as Ki-67, PI3K and gene expression assays, the College of American Pathologists (CAP), the 
American Society of Clinical Oncologists (ASCO) and the National Comprehensive Cancer Network (NCCN) 
have not recognized these markers in patient treatment pathways.  
 
Estrogen receptor (ER), progesterone receptor (PR) and epidermal growth factor receptor 2 (Her2) are well-
established prognostic markers in invasive breast cancer management. The triple negative breast carcinoma 
subtype (ER-/PR-/Her2-) has been associated with worse overall prognosis in comparison with other subtypes 
in study populations consisting of ethnic minorities and young women.  
 
Ki-67 expression is a biomarker for proliferation and has been associated with response to therapy, but methods 
of measurement are controversial. In December, 2013, the CAP reported that there is a lack of consensus on 
scoring, definition of low versus high expression, an appropriate cut point for positivity, or which part of the 
tumor should be scored (e.g., leading edge, hot spots, overall average). There is also paucity of data on the 
effects of pre-analytical variables (e.g., ischemic time, length of fixation, antigen retrieval) on Ki-67 staining. 
For these reasons, routine testing of breast cancers for Ki-67 expression is not currently recommended by either 
ASCO or the NCCN." Consequently, Ki-67 is not reasonable and necessary for breast cancer and will not be 
covered by Medicare.  
 
The clinical utility of testing for hormone receptors in in-situ breast cancer differs from those of invasive 
disease. Guidelines and the peer reviewed literature support the use of ER testing for in-situ breast neoplasia 
and PR testing only when the ER status is negative (Lester, personal communication). Clinical guidelines have 
not been established for the use of Her2 or other biomarkers in patients with non-invasive breast neoplasia.  
 
In the absence of professional guidelines based on proven scientific literature, standing orders from clinicians 
for such tests as Ki-67 and EGFR on every breast cancer are not reasonable and necessary, and are not a 
covered Medicine service.  
 
In addition, basal phenotype markers (eg, IHC for CK5) are not routinely necessary. Neither are IHC stains 
such as E-cadherin, p27, or high molecular weight cytokeratin to distinguish ductal from lobular differentiation necessary on every breast case, nor are myoepithelial cell markers such as p63 or smooth muscle myosin heavy 
chain necessary on every case.  
 
You can find this information in the Local Coverage Determination (LCD) Lab: Special Histochemical Stains 
and Immunohistochemical Stains L36351. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.