Non-FDA Approved Use denials: 43.6% overturned by independent reviewers
In 383 California IMR decisions from 2002 to 2011, reviewers overturned the plan 167 times (43.6%). Denials reach IMR only when a member appeals all the way; read the caveats below before generalising.
By diagnosis
| Diagnosis category | Decisions | Overturned | Last 5 years |
|---|---|---|---|
| CNS/ Neuromusc Dis | 80 | 50.0% | — |
| Orth/Musculoskeletal | 68 | 38.2% | — |
| Mental Disorder | 54 | 38.9% | — |
| Digestive System/ GI | 29 | 41.4% | — |
| Respiratory System | 28 | 35.7% | — |
| Cancer | 21 | 33.3% | — |
| Immuno Disorders | 19 | 31.6% | — |
| Endocrine/Metabolic | 17 | 76.5% | — |
| Skin Disorders | 12 | 66.7% | — |
| Infectious Disease | 11 | 45.5% | — |
| Blood Related Disord | 10 | 50.0% | — |
| OB-GYN/ Pregnancy | 7 | 14.3% | — |
| Cardiac/Circ Problem | 7 | 57.1% | — |
| GU/ Kidney Disorder | 5 | 60.0% | — |
What the findings mention
| What the findings mention | Decisions | Overturned | All decisions here |
|---|---|---|---|
| FDA approval or off-label use discussedThe findings discuss the FDA label status of the treatment. | 74 | 37.8% | 43.6% |
| Published evidence citedThe findings refer to peer-reviewed or published evidence. | 51 | 35.3% | 43.6% |
| Prior therapies failedThe findings mention treatments that were tried without adequate response. | 43 | 74.4% | 43.6% |
| Records did not supportThe findings say the documentation did not show what was needed (usually an upheld denial). | 23 | 8.7% | 43.6% |
| Experimental or investigationalThe findings discuss whether the treatment is experimental. | 21 | 14.3% | 43.6% |
| Step therapy or fail-firstThe findings mention a fail-first requirement. | 11 | 63.6% | 43.6% |
| Alternatives contraindicatedThe findings mention a contraindication to the plan's preferred option. | 11 | 45.5% | 43.6% |
| Guidelines or criteria citedThe findings cite guidelines, criteria or a standard of care. | 6 | 0.0% | 43.6% |
| Urgent or emergencyThe findings mention urgency. | 5 | 60.0% | 43.6% |
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
“The parent of a one-year-old female enrollee has requested for anakinra (Kineret®) for treatment of the enrollee’s cryopyrin-associated periodic syndrome. Findings: The physician reviewer found that the scientific data indicates that CAPS is due to excessive IL1 beta release. The medication Kineret inhibits IL1 receptors, and moderates various types of inflammatory processes. While use of Kineret is currently not specifically …”
“A 54-year-old male enrollee has requested Lyrica for treatment of his pain. Findings: The physician reviewer found that the treatment of neuropathic pain of any etiology can be managed with membrane stabilizing agents such as Lyrica and Neurontin. These medications are generally part of first-line therapy and are an integral part of a comprehensive management strategy for difficult to control …”
“A 35-year-old female enrollee has requested coverage for rituximab for treatment of her neuromyelitis optica. Findings: Two physician reviewers found that she has relapsing-remitting multiple sclerosis and neuromyelitis optica. As a result of her disease, the patient has experienced weakness, and she has had multiple severe relapses requiring ventilator support. The patient has failed therapy with Avonex and Tysabri. Her …”
- 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 overturned?
In 383 California IMR decisions from 2002 to 2011, reviewers overturned the plan 167 times (43.6%).
What did the reviewers' findings mention in overturned cases?
The table on this page counts keyword matches in the findings: prior therapies tried, contraindications, guidelines cited, published evidence, whether the records supported the request. They describe what the findings say, not why the case was decided.
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 the reasoning is the same kind: criteria, documentation and alternatives. Use the findings as a guide to what to document.
Related: California appeal rights · California external-review reversal rate · The levers library · CSV
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.