Non-FDA Approved Use for Cancer: 33.3% of denials overturned
In 21 California IMR decisions from 2004 to 2010, reviewers overturned 7 (33.3%). 13 were medical-necessity disputes, 8 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. | 5 | 0.0% | 33.3% |
| Published evidence citedThe findings refer to peer-reviewed or published evidence. | 4 | 0.0% | 33.3% |
| FDA approval or off-label use discussedThe findings discuss the FDA label status of the treatment. | 3 | 100.0% | 33.3% |
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 35-year-old female enrollee has requested Tarceva 150mg for the treatment of her metastatic lung cancer. Findings: The physician reviewer found that Tarceva is approved for use in non-small cell carcinoma of the lung after failure of first-line chemotherapy. However, there appears to be certain situations wherein there is a particularly good chance of a response without the side effects …”
“A 32-year-old male has requested Sutent for treatment of acute myeloid leukemia (AML). Findings: Two physician reviewers found that Sutent, a multi-targeted tyrosine kinase inhibitor, has shown activity in a number of solid tumors, especially advanced renal cell carcinoma (RCC) and gastrointestinal stromal tumors (GIST), for which it is FDA approved. Sutent has been studied in AML. There is no …”
“A 57-year-old female enrollee has requested the prescription medication Provigil for the treatment of her depression and daytime somnolence. Findings: The physician reviewer found that providing a supplemental medication to relieve these symptoms is appropriate. Ritalin and Dexedrine were limited in their efficacy and were not well tolerated. In contrast, the patient responded well to Provigil without the nervousness she …”
And one the reviewer upheld
“A 36-year-old male enrollee has requested Zolinza 100mg for treatment of his glioblastoma multiforme. Findings: The physician reviewer found that Zolinza (vorinostat) is a relatively new drug that falls into the class of histone deactylase inhibitors. These drugs can induce cell growth arrest, differentiation or cell death. This medication has been approved for use in cutaneous T-cell lymphomas. There are …”
- 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 Non-FDA Approved Use denials for Cancer overturned?
In 21 California IMR decisions from 2004 to 2010, reviewers overturned 7 (33.3%). 13 were medical-necessity disputes, 8 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.