Investigational Tx denials: what the review data shows
Independent reviewers have decided 145 published cases where an insurer denied Investigational Tx — and they overturned the insurer 44.1% of the time. A denial for Investigational Tx is a starting position, not a final answer.
Conditions behind investigational tx denials
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. | 135 | 41.5% |
Medical Necessity The plan said the care wasn’t medically necessary. The most common fight, and the most winnable. | 10 | 80% |
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 47-year-old male diagnosed with a high-grade pleomorphic sarcoma of the left supraclavicular fossa. The recommendation of the treating oncologist was for a dose of 60 Gy delivered in 30 fractions to the left supraclavicular area. A post-treatment note from April 2005 indicated the PET and CT scan revealed no solid evidence of recurrence, however, a note dated July 2006 indicated a locally recurrent high-grade pleomorphic sarcoma interposed between the left scapula, clavicle and chest wall, occurring two years after neoadjuvant chemotherapy, surgical resection and post-operative radiation therapy. According to the radiation oncologist, the superior aspect of the patient’s recurrence was clearly within his prior radiation therapy portal, with the inferior aspect of it appearing to extend beneath the inferior margin on the portal.
Where the denial was upheld
Physician 1: The patient is a 63-year-old female first diagnosed with breast cancer in early 1999. At that time she underwent mastectomy, followed by adjuvant chemotherapy with Adriamycin and Cytoxan, then taxotere. She was then well for five years when she developed recurrence in a supraclavicular node, which was completely resected. No other metastatic disease was found, and she has been receiving further chemotherapy. It is proposed that she be treated with high dose chemotherapy and autologous stem cell rescue. The use of this treatment is the subject of this appeal. For many years, the use of high dose chemotherapy (HDC) with peripheral stem cell transplant (PSCT) has been a very controversial treatment in breast cancer. Primarily, it has been studied in two very separate situations.
Physician 1: This patient is a 62-year-old male diagnosed with hepatocellular carcinoma in July 2004. The tumor was resected and no further treatment was provided at that time. The patient did well until November 2005 when he was found to have an abdominal nodule positive for recurrence. CT and PET scans revealed multiple lung metastases. He was treated with an investigational agent, which did not halt the progression of his disease. In April 2006 the patient began chemotherapy with cisplatin, 5-FU, interferon and Avastin. The patient’s request for reimbursement and prospective authorization for Avastin and interferon was denied by the Health Plan citing the experimental/investigational nature of the therapy.Overall chemotherapy has been of little benefit in metastatic hepatocellular carcinoma.
Figures and quotations on this page come from 42,749 published decisions in the California DMHC Independent Medical Review dataset. These are California outcomes — every state runs an equivalent external review, but the rates here are California’s. Excerpts are quoted verbatim from the public record and describe this treatment generally, not any individual case.
These are outcomes from California’s external review program — an independent physician panel that binds the insurer. Every state has an equivalent process, and internal appeals succeed even more often. Cite the outcome record for Investigational Txwhen you appeal: reviewers routinely find that denials like yours didn’t hold up.
SOURCE: CALIFORNIA DMHC INDEPENDENT MEDICAL REVIEW OUTCOMES (CHHS OPEN DATA) · DERIVED AGGREGATE STATISTICS ONLY · METHODOLOGY