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Certificate of Medical Necessity:
Assays of Genetic Expression in Tumor Tissue
as a Technique to Determine Prognosis in Patients
with Breast Cancer (Oncotype DX™)
For Pre-Service: Statewide Fax (877) 219-9448
For Medicare Advantage (BlueMedicare) HMO and PPO Plans: Fax (904) 301-1614
Fax or mail this
completed form
Physician Information/
Requesting Provider
to:
For Post-Service Claims:
Florida Blue
P.O. Box 1798
Jacksonville, FL 32231-0014
Name:
BCBSF No:
Contact Name:
Facility Information/
Location where services
will be rendered
Member Information
Procedure Information
Name:
National Provider Identifier (NPI):
Phone:
BCBSF No:
National Provider Identifier (NPI):
Contact Name:
Phone:
Last Name:
First Name:
Member/Contract Number (alpha and numeric):
Date of Birth:
Procedure Code(s):
Procedure Description:
Diagnosis code(s):
Diagnosis Description:
Date of Service/Tentative Date:
Section B
Medical Necessity: For detailed information on assays of genetic expression in tumor tissue as a technique to determine prognosis in patients
with breast cancer (Oncotype DX™) including the criteria that meet the definition of medical necessity, visit the Florida Blue
Medical Coverage Guideline website at http://mcgs.bcbsfl.com. Refer to Medical Coverage Guideline 05-86000-26, Assays
of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer (Oncotype
DX™.) For Medicare members, refer to http://www.cms.gov/medicare-coverage-database, Local Coverage Determination
(LCD) Gene Expression Profiling Panel for use in the Management of Breast Cancer Treatment L33541.
Section C
Check all boxes and complete all entries that apply:
Yes
No
Is this request for a new diagnosis of breast cancer (6 months or less)?
Date of diagnosis:
Yes
No
Is the diagnosis a unilateral tumor?
Yes
No
Is the member node-negative (lymph nodes with micrometastases (less than 2 mm in size) are considered node negative)
OR is there 1-3 involved ipsilateral axillary lymph nodes?
Yes
No
Is the tumor hormone-receptor-positive (ER-positive or PR-positive)?
Yes
No
Is the tumor HER2-negative?
Yes
No
Is the tumor size greater than 0.5 cm?
Describe:
Yes
No
Will the member be treated with hormonal therapy?
Certificate of Medical Necessity:
Assays of Genetic Expression in Tumor Tissue as a Technique to
Determine Prognosis in Patients with Breast Cancer (Oncotype DX™)
CMN 05-86000-26_111515
1
Yes
No
Is the member a candidate for chemotherapy?
Yes
No
Has the member had surgery?
Yes
No
Has a full pathological examination of the tumor been completed?
Yes
No
Will the test result determine if adjuvant chemotherapy will be used?
Explain:
Yes
No
Is the test being ordered by the treating physician?
Yes
No
Is the use of Oncotype DX to determine recurrence risk for deciding whether or not to undergo adjuvant chemotherapy?
Explain:
Yes
No
Is the requested service a gene expression test other than Oncotype DX?
(i.e., MammaPrint, Mammostrat or Breast Cancer Index)
Additional Comments:
I hereby certify that (i) I am the treating physician for above member, (ii) the information contained in and included with this Certificate of Medical Necessity is true, accurate and
complete to the best of my knowledge and belief, (iii) the member’s medical records contain all appropriate documentation necessary to substantiate this information. I acknowledge
that a determination made based upon this Certificate of Medical Necessity is not necessarily a guarantee of payment and that payment remains subject to application of the
provisions of the member’s health benefit plan, including eligibility and plan benefits. Additionally, I further acknowledge and agree that Florida Blue may audit or review the underlying
medical records at any time and that failure to comply with such request may be a basis for the denial of a claim associated with such services.
Ordering Physician’s Signature:
Certificate of Medical Necessity:
Date:
Assays of Genetic Expression in Tumor Tissue as a Technique to
Determine Prognosis in Patients with Breast Cancer (Oncotype DX™)
2