Oncotype Dx Assay denials in California external review
In the California DMHC record, independent physician reviewers decided 26 published external-review cases involving Oncotype Dx Assayand overturned the plan’s denial in 73.1%. That is a historical result among cases that reached this program, not a forecast for an individual appeal.
By condition
| Condition | Decisions | Overturned |
|---|---|---|
| Breast Cancer | 16 | 81.2% |
What the insurer actually argued
| Reason given | Decisions | Overturned |
|---|---|---|
Experimental/Investigational The plan called the treatment unproven. These turn on published evidence, so the appeal is a literature argument. | 18 | 72.2% |
Medical Necessity The plan said the care wasn’t medically necessary. The most common fight, and the most winnable. | 8 | 75% |
What the reviewers wrote
Where the denial was overturned
Physician 1: The patient is a 53-year-old woman diagnosed with infiltrating lobular carcinoma in July 2000 and subsequently diagnosed with ipsilateral invasive ductal cancer in January 2005. She was found to have a 1.4cm tumor with positive estrogen receptors and negative axillary nodes. The patient underwent an Oncotype DX assay and had a recurrence score of 17 which predicts an 11% chance of recurrence if the patient is not treated with chemotherapy. On that basis, the decision was made to forgo adjuvant chemotherapy.
Physician 1: The patient is a 65-year-old woman who has been diagnosed with two breast cancers. In October 2004 she was found to have a moderately differentiated 1cm invasive ductal cancer with negative sentinel node and positive estrogen receptor. Her cancer was submitted to Oncotype DX assay, and was found to have a score of 11, which corresponds to a 7% risk of recurrence within 10 years if treated with hormonal therapy alone. Because on these findings, adjuvant chemotherapy was not recommended.In December 2005 she was found to have a second cancer, this time in the other breast. Findings revealed a 0.6cm well differentiated invasive lobular carcinoma with negative nodes and positive estrogen receptor. This cancer was also submitted to an Oncotype DX assay, and was found to have a score that placed the patient at a 35% risk of recurrence.
Where the denial was upheld
Physician 1: This patient is a 55-year-old woman diagnosed with breast cancer in September 2005. At that time she was found to have a 1.5 cm invasive ductal carcinoma, intermediate grade, with negative nodes. The estrogen receptor was positive and HER2 was positive. Her tissue was submitted for “Oncotype DX” assay. This assay gave her a risk of recurrence of 34%. Accordingly, she underwent adjuvant chemotherapy. The Health Plan deemed the diagnostic procedure experimental/investigational and denied her request for reimbursement.The decision as to the appropriateness of adjuvant chemotherapy is a difficult one in Stage I breast cancer. The “Oncotype DX” assay does appear to add meaningful prognostic information in this situation.
Physician 1: The patient is a 59-year-old woman diagnosed with breast cancer in November 2005. At that time she was found to have multiple foci of invasive ductal breast cancer, the largest of which was 1.9cm. It was of intermediate grade histologically. Estrogen receptor was strongly positive and HER-2 was negative. The patient underwent an Oncotype DX tumor assay for which she has requested reimbursement. The Health Plan has denied her request on the basis that the Oncotype DX assay is considered investigational.Oncotype DX assay is a 21-gene analysis of breast cancer cells, which produces a recurrence score that predicts quite accurately the risk of distant recurrence of the cancer by ten years if the patient is treated with hormonal therapy alone.However, thus far all the validated data has been only in patients with estrogen receptor positive, node-negative tumors.
Figures and quotations on this page come from 42,749 published decisions in the California DMHC Independent Medical Review dataset. These are California external-review outcomes. Other state and federal programs have different eligibility rules, processes, and current availability; the rates here do not transfer to those programs or predict an individual result. Excerpts are quoted verbatim from the public record and describe this treatment generally, not any individual case.
These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Oncotype Dx Assay, then check the rights and deadlines that apply to your plan.
SOURCE: CALIFORNIA DMHC INDEPENDENT MEDICAL REVIEW OUTCOMES (CHHS OPEN DATA) · AGGREGATES + DEIDENTIFIED DECISION EXCERPTS/REFERENCE IDS · METHODOLOGY