Afirma Gene Expression Classifier Testing denials in California external review
In the California DMHC record, independent physician reviewers decided 14 published external-review cases involving Afirma Gene Expression Classifier Testingand overturned the plan’s denial in 100%. That is a historical result among cases that reached this program, not a forecast for an individual appeal.
Conditions behind Afirma Gene Expression Classifier Testing denials
| Category | Decisions | Overturned |
|---|---|---|
| Thyroid Nodule With Indeterminate Cytology | 5 | 100% |
What the reviewers wrote
Where the denial was overturned
Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Afirma Gene Expression Classifier testing for evaluation of the enrollee’s thyroid nodules. Findings: The physician reviewer found that The physician reviewer found that while a fine needle aspiration biopsy of a suspicious thyroid nodule is typically an accurate means of assessing whether the nodule is benign or malignant, approximately 15% of fine needle aspiration biopsy results are considered to be indeterminate. Until recently, the only way to establish whether the nodule was thyroid cancer was via surgical excision, even though the majority of the cases turn out to be benign.
Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the Afirma Gene Expression Classifier (GEC) testing. The Bethesda System recommends a diagnostic hemithyroidectomy for this type of nodule. The recent American Thyroid Association guidelines state that for nodules with atypical of undetermined significance “cytology, after consideration of worrisome clinical and sonographic features, investigations such as repeat fine needle aspiration (FNA) or molecular testing may be used to supplement malignancy risk assessment in lieu of proceeding directly with a strategy of either surveillance or diagnostic surgery”. If the genetic test is suspicious, the risk of malignancy increases to 40% and the risk of malignancy decreases to less than 6% with benign findings. In this case, the result of the Afirma GEC was suspicious for malignancy.
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 Afirma Gene Expression Classifier Testing, 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