Clin Trial (II - IV) for Cancer: 52.9% of denials overturned
In 17 California IMR decisions from 2003 to 2017, reviewers overturned 9 (52.9%). 5 were medical-necessity disputes, 12 experimental/investigational.
What the findings mention
| What the findings mention | Decisions | Overturned | All decisions here |
|---|---|---|---|
| Experimental or investigationalThe findings discuss whether the treatment is experimental. | 8 | 50.0% | 52.9% |
| FDA approval or off-label use discussedThe findings discuss the FDA label status of the treatment. | 3 | 33.3% | 52.9% |
Keyword matches on the reviewer’s findings, not causes. A tag that appears mostly in overturned decisions is worth documenting in an appeal; it is not a guarantee.
From recent overturned decisions
“A 46-year-old male has requested participation in Phase III Clinical Trial Evaluating DCVax®-L, Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen for the Treatment of Glioblastoma Multiforme. Findings: The physician reviewer found that chemotherapy prolongs survival with modest gains in some patients with GBM. The standard of care is to resect the GBM maximally followed by treatment with temozolomide. The …”
“A 63-year-old female enrollee has requested for participation in the requested phase 1-2 clinical trial for Hana Biosciences Marqibo for treatment of her choroidal melanoma with liver and lung metastases. Findings: Two physician reviewers found that the rare form of melanoma found in this case is a very uncommon, highly aggressive malignancy for which no standard therapy exists. This patient …”
“A 49-year-old male enrollee has requested participation in a Phase III clinical trail at the University of Arkansas (UARK 2006-15) for treatment of his multiple myeloma. Findings: Two physician reviewers found that the Phase III trial in question seeks to determine the `standard of care` for patients with multiple myeloma. All of the agents being used are indicated in the …”
And one the reviewer upheld
“Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for gene testing for evaluation of the enrollee’s recto-sigmoid cancer. Findings: Two physician reviewers found that the gene testing provided was not likely to be more beneficial for evaluation of the patient’s medical condition than any available standard therapy. Genetic testing of a tumor offers a comprehensive panel of molecular …”
- California only: these are decisions by independent reviewers under California's IMR program (plans regulated by the Department of Managed Health Care). Other states and self-funded employer plans use different reviewers and rules.
- Selection: only denials that a member took all the way to IMR appear. Most denials are never appealed, and the ones that reach an external reviewer are not a random sample.
- Overturned means the reviewer disagreed with the plan; it does not mean the treatment worked or that a similar request will be approved.
- Argument tags are keyword matches on the reviewer's findings. They describe what the findings mention, not why the case was decided.
- Categories are DMHC's own labels (treatment sub-category and diagnosis category); 'Other' is a catch-all and is excluded from rankings.
Source: California Department of Managed Health Care, Independent Medical Review (IMR) Determinations, Trend (CHHS Open Data). Public California government data; Apellica's aggregates and tags are CC BY 4.0.
Questions
How often were Clin Trial (II - IV) denials for Cancer overturned?
In 17 California IMR decisions from 2003 to 2017, reviewers overturned 9 (52.9%). 5 were medical-necessity disputes, 12 experimental/investigational.
What should an appeal document, based on these findings?
Whatever the plan's criteria ask for, shown in the record: the treatments already tried and their results, contraindications to the plan's preferred option, the guideline or evidence that supports the request, and the treating clinician's reasoning written to the criteria. The tag table shows which of these the reviewers mentioned most in overturned cases.
Does a California IMR result apply to my plan?
Only California plans regulated by the Department of Managed Health Care go to IMR. Other states and self-funded employer plans use different reviewers, but they weigh the same things.
Independent reviewers reverse plans when the record answers the criteria. Upload the denial letter; a senior reviewer reads it within 24 hours and tells you in writing whether it can be appealed and how. $0 upfront, 10% of what is recovered, nothing if we do not recover. Not a law firm.