Non-FDA Approved Use for CNS/ Neuromusc Dis: 50.0% of denials overturned
In 80 California IMR decisions from 2003 to 2011, reviewers overturned 40 (50.0%). 65 were medical-necessity disputes, 15 experimental/investigational.
What the findings mention
| What the findings mention | Decisions | Overturned | All decisions here |
|---|---|---|---|
| Prior therapies failedThe findings mention treatments that were tried without adequate response. | 16 | 75.0% | 50.0% |
| Published evidence citedThe findings refer to peer-reviewed or published evidence. | 11 | 36.4% | 50.0% |
| FDA approval or off-label use discussedThe findings discuss the FDA label status of the treatment. | 9 | 33.3% | 50.0% |
| Experimental or investigationalThe findings discuss whether the treatment is experimental. | 8 | 25.0% | 50.0% |
| Step therapy or fail-firstThe findings mention a fail-first requirement. | 4 | 50.0% | 50.0% |
| Records did not supportThe findings say the documentation did not show what was needed (usually an upheld denial). | 4 | 0.0% | 50.0% |
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 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 …”
“A 58-year-old male enrollee has requested for Lyrica for treatment of his peripheral neuropathy. Findings: The physician reviewer found that the patient has painful neuropathy due to immunosuppressant medications. The mechanism of the neuropathy is different than in diabetic or post-herpetic neuropathies, but the mechanism of pain transmission and the symptoms are the same. Therefore, the management of these neuropathies …”
“A 48-year-old male enrollee has requested Rituxan for treatment of his multiple sclerosis. Findings: Three physician reviewers found that although additional studies are warranted, there is adequate literature supporting the use of Rituxan in the treatment of patients with MS to support its use in this case. In one study conducted by Bar-Or and colleagues, the safety, tolerability and effectiveness …”
And one the reviewer upheld
“A 55-year-old female enrollee has requested Nuvigil 250 mg. for treatment of her medical condition of excessive sleepiness. Findings: The physician reviewer found that upon reviewing this patient’s records, there does not appear to be evidence of a diagnosis of obstructive sleep apnea, narcolepsy or shift work sleep disorder. In the current medical literature, there is insufficient support for the …”
- 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 CNS/ Neuromusc Dis overturned?
In 80 California IMR decisions from 2003 to 2011, reviewers overturned 40 (50.0%). 65 were medical-necessity disputes, 15 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.