CurrentMassachusetts Executive Office of Health and Human ServicesPolicy N/A

Guidelines for Medical Necessity Determination for Gene Expression Profiling Tests for Breast Cancer

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This policy establishes MassHealth medical-necessity and prior-authorization requirements for gene expression profiling, primarily Oncotype DX, in patients with newly diagnosed early-stage breast cancer. It specifies eligible clinical characteristics, documentation, ordering and laboratory requirements, and circumstances in which testing is not medically necessary.

Policy Summary

PayerMassachusetts Executive Office of Health and Human Services

PolicyGene Expression Profiling Tests for Breast Cancer

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMar 15, 2016

Next Review DateN/A

Key ActionSubmit prior authorization with clinical documentation supporting medical necessity for gene expression profiling requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Oncotype DXCovered test

21 genes

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CurrentMassachusetts Executive Office of Health and Human ServicesPolicy N/A

Guidelines for Medical Necessity Determination for Gene Expression Profiling Tests for Breast Cancer

Customize your policy alerts

Sign up for all Massachusetts Executive Office of Health and Human Services policy alerts

Know when Massachusetts Executive Office of Health and Human Services releases new policies or updates existing guidance.

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Policy Summary

PayerMassachusetts Executive Office of Health and Human Services

PolicyGene Expression Profiling Tests for Breast Cancer

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMar 15, 2016

Next Review DateN/A

Key ActionSubmit prior authorization with clinical documentation supporting medical necessity for gene expression profiling requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Oncotype DXCovered test

21 genes

I-IIStages described

3Recurrence-score categories

81519Covered procedure code

3Explicit noncoverage examples

Coverage Criteria

Oncotype DX Initial Coverage Criteria

Covered on a case-by-case basis when ALL of the following criteria are met:

ALL of the following

Gene expression profiling testing is being done specifically to guide the decision as to whether adjuvant chemotherapy will be used. The patient and oncologist must have discussed the potential results of the test and agree to use the results to guide therapy before testing.
The gene expression profiling test is ordered by the treating oncologist or by a pathologist who submits documentation of a tumor board discussion.
Breast cancer is newly diagnosed.
Breast cancer histology is ductal, lobular, mixed, or metaplastic.
The breast tumor is hormone receptor-positive (estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive).
The breast tumor is HER2-receptor negative.
Breast cancer is non-fixed (i.e., the tumor is not adhered to the chest wall).
The breast cancer tumor is greater than 5 mm.> 5 mm
Tumor stage and treatment requirements
- The tumor stage is pT1, pT2, or pT3; is nonmetastatic (pN0) or has axillary lymph node micrometastases less than or equal to 2 mm (pN1mi).
- Breast cancer will be treated with hormonal therapy.
- Adjuvant chemotherapy is not precluded due to any other factor, such as advanced age and/or significant co-morbidities.
Gene expression profiling may be considered on a case-by-case basis for patients with tumors with one to three ipsilateral axillary nodes with micrometastases, as described in the tumor-stage criterion above, who otherwise meet the criteria.
The test must be performed by a MassHealth contracting laboratory facility.

Gene expression profiling to predict response to specific chemotherapy regimens is not medically necessary.

Repeat testing or testing of multiple tumor sites in the same patient is not medically necessary.

Gene expression profiling tests other than Oncotype DX™ are not medically necessary.

MassHealth does not consider gene expression profiling to be medically necessary under certain circumstances. The noncoverage circumstances described above include, but are not limited to, these examples.

Coding and Clinical Classification

Gene expression profiling procedure codeCPTCovered

81519

Oncology (breast), mRNA, gene expression profiling by real time RT-PCR of 21 genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as recurrence score

Recurrence score categories

Low recurrence scoreRS <18

Intermediate recurrence scoreRS 18–30

High recurrence scoreRS ≥31

Tumor size criterion

Tumor size requirementGreater than 5 mm

Applies toThe breast cancer tumor

Coverage contextRequired for case-by-case consideration of Oncotype DX coverage

Provider Actions and Submission Requirements

Prior Authorization

Prior Authorization Required

A prior authorization (PA) request is required for gene expression profiling. The request must include supporting clinical documentation demonstrating medical necessity; approval remains subject to MassHealth eligibility, other insurance, and program restrictions.

Submit through the Provider Online Service Center (POSC) or with a MassHealth Prior Authorization Request (PA-1) form and pertinent attachments.

Documentation Required

Ordering and Laboratory Requirements

The test must be ordered by the treating oncologist or by a pathologist who submits documentation of a tumor board discussion. Testing must be performed by a MassHealth-contracting laboratory facility.

The patient and oncologist must discuss the potential results and agree before testing to use them to guide the adjuvant chemotherapy decision.

Background

Gene expression profiling compares gene expression in normal and malignant cells to help subclassify breast cancer, estimate recurrence risk, and inform the likely benefit of therapy. For selected patients with early-stage, hormone receptor-positive, HER2-negative breast cancer, the Oncotype DX 21-gene assay generates a recurrence score intended to help guide the decision about adjuvant chemotherapy.

Definitions

Oncotype DX

Assay typeMultiplex, 21-gene, real-time PCR-based assay

SpecimenBreast tumor tissue

Result generationUses a mathematical algorithm to generate a breast cancer recurrence score

Recurrence score (RS)

DefinitionAlgorithm-generated score estimating breast cancer recurrence risk

Low riskRS <18

Intermediate riskRS 18–30

Covered Indications

Oncotype DX for Selected Patients With Newly Diagnosed Early-Stage Breast Cancer

Oncotype DX gene expression profiling is covered on a case-by-case basis for selected patients with newly diagnosed early-stage breast cancer when the result will guide the decision whether to use adjuvant chemotherapy and all of the following criteria are met.

Required clinical criteria

Treatment decision: Testing is performed specifically to guide the decision whether adjuvant chemotherapy will be used; the patient and oncologist discussed the potential results of the test and agreed before testing to use the results to guide therapy.
ONE of
- The test is ordered by the treating oncologist.
- The test is ordered by a pathologist who submits documentation of a tumor board discussion.

Not Covered

The following uses are not covered because they are not considered medically necessary: gene expression profiling tests other than Oncotype DX; repeat testing or testing of multiple tumor sites in the same patient; and testing intended to predict response to specific chemotherapy regimens.

Policy Summary

PayerMassachusetts Executive Office of Health and Human Services

PolicyGene Expression Profiling Tests for Breast Cancer

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMar 15, 2016

Next Review DateN/A

Key ActionSubmit prior authorization with clinical documentation supporting medical necessity for gene expression profiling requests.

SourceLink

On This Page

Tumor stage criterion

Qualifying stagespT1, pT2, or pT3

Disease statusNonmetastatic disease (pN0) or qualifying axillary lymph node micrometastases

Clinical applicationPart of the criteria for case-by-case Oncotype DX coverage consideration

Nodal disease criteria

Nonmetastatic diseasepN0

Micrometastatic diseasepN1mi axillary lymph node micrometastases measuring ≤2 mm

Limited ipsilateral nodal diseaseOne to three ipsilateral axillary nodes with micrometastases may be considered case by case when the patient otherwise meets the criteria

Documentation Required

Required Medical-Necessity Documentation

Medical-necessity documentation must accompany the PA request and include the completed, signed and dated test request; diagnosis information; relevant clinical history; and documentation showing how the results will guide treatment.

A copy of the completed test request form signed and dated by the oncologist or pathologist.
Primary diagnosis name, current ICD code, and date of diagnosis.
Secondary diagnoses and current ICD codes pertinent to comorbid conditions.
Most recent medical evaluation, including medical history, last physical examination, comorbid conditions, and current medications.
Summary of previous surgeries and hospitalizations.
Current therapy and intention to use the test results to guide the decision whether adjuvant chemotherapy will be used.
Any other clinical information MassHealth requests.

Documentation Required

Required Pathology Details

Include the report of the breast tumor’s pathological evaluation with the findings needed to assess coverage and medical necessity.

Tumor size.
Histology.
Tumor grade.
Presence or absence of estrogen and/or progesterone hormone receptors.
Presence or absence of HER2 receptors.
Tumor staging, including presence or absence of affected lymph nodes and the sizes of affected nodes.

Documentation Required

Submitting Clinician Documentation

Clinical information must be submitted by the treating oncologist or by a pathologist who also submits documentation of a tumor board discussion. Submit all information pertinent to the diagnosis through POSC or with the PA-1 form and attach the supporting documentation.

Providers are strongly encouraged to submit requests electronically through POSC.
For paper submission, use the PA-1 form available through MassHealth and mail the form and documentation to the address on the back of the form.
POSC access questions may be directed to the MassHealth Customer Service Center at 1-800-841-2900.

Denial Risk

Noncovered Uses and Tests

MassHealth does not consider gene expression profiling medically necessary in the following circumstances.

Predicting response to specific chemotherapy regimens.
Repeat testing or testing multiple tumor sites in the same patient.
Gene expression profiling tests other than Oncotype DX™.

Denial Risk

Failure to Meet Clinical Criteria

Coverage requires the qualifying patient, tumor, treatment, ordering, laboratory, and documentation criteria below. Failure to meet the applicable clinical criteria may result in denial of the PA request.

Testing is specifically intended to guide the decision whether to use adjuvant chemotherapy, and the patient and oncologist agreed before testing to use the results for that decision.
Breast cancer is newly diagnosed and has ductal, lobular, mixed, or metaplastic histology.
The tumor is hormone receptor-positive (ER-positive and/or PR-positive) and HER2-receptor negative.
The tumor is non-fixed, meaning it is not adhered to the chest wall, and is greater than 5 mm.
Tumor stage is pT1, pT2, or pT3; disease is nonmetastatic (pN0) or has axillary lymph-node micrometastases no greater than 2 mm (pN1mi). Gene expression profiling may be considered case-by-case for tumors with one to three ipsilateral axillary nodes with micrometastases that otherwise meet the criteria.
The cancer will be treated with hormonal therapy, and adjuvant chemotherapy is not precluded by another factor, such as advanced age or significant comorbidities.
The test is ordered by the treating oncologist or by a pathologist with tumor board discussion documentation and is performed by a MassHealth-contracting laboratory facility.

Note

Provider Actions

The treating oncologist may order the test. A pathologist may order it only when documentation of a tumor board discussion is submitted with the clinical information and PA request.

Ensure the required medical-necessity and pathology documentation is complete before submission.
Document the tumor board discussion when the pathologist is the ordering clinician.

Non-fixed breast tumor

DefinitionA breast tumor that is not adhered to the chest wall

Clinical termNon-fixed breast tumor

Coverage relevanceNon-fixed status is one of the clinical criteria for Oncotype DX consideration

Axillary lymph node micrometastases

Clinical designationpN1mi

DefinitionAxillary lymph node micrometastases

Maximum sizeLess than or equal to 2 mm

Histology and receptor status

ONE of
- Histology is ductal.
- Histology is lobular.
- Histology is mixed.
- Histology is metaplastic.
The tumor is hormone receptor-positive, defined as estrogen receptor-positive and/or progesterone receptor-positive.
The tumor is HER2-receptor negative.

Tumor characteristics

Breast cancer is newly diagnosed.
The tumor is non-fixed, meaning it is not adhered to the chest wall.
The tumor is greater than 5 mm.>5 mm

Stage and nodal status

Tumor stage is pT1, pT2, or pT3.pT1, pT2, or pT3
ONE of
- Disease is nonmetastatic (pN0).
- Disease has axillary lymph node micrometastases measuring less than or equal to 2 mm (pN1mi).≤2 mm
- The patient has one to three ipsilateral axillary nodes with micrometastases and is considered case by case, otherwise meeting the applicable criteria.
  Case-by-case consideration applies to tumors with one to three ipsilateral axillary nodes with micrometastases.

Treatment eligibility

Breast cancer will be treated with hormonal therapy.
Adjuvant chemotherapy is not precluded by another factor, such as advanced age or significant comorbidities.

Laboratory requirement: The test is performed by a MassHealth contracting laboratory facility.