Non-FDA Approved Use for Immuno Disorders: 31.6% of denials overturned
In 19 California IMR decisions from 2003 to 2011, reviewers overturned 6 (31.6%). 18 were medical-necessity disputes, 1 experimental/investigational.
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. | 8 | 25.0% | 31.6% |
| Published evidence citedThe findings refer to peer-reviewed or published evidence. | 6 | 33.3% | 31.6% |
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 61-year-old female enrollee has requested Lyrica for treatment of her fibromyalgia. Findings: The physician reviewer found that Lyrica is medically indicated for the patient’s medical condition of fibromyalgia. Lyrica is FDA approved for fibromyalgia. Mease and colleagues evaluated the efficacy and safety of pregabalin (Lyrica) for symptomatic relief of pain associated with fibromyalgia and for management of fibromyalgia in …”
“A 26-year-old female enrollee has requested Lyrica 150mg twice daily for treatment of fibromyalgia and depression. Findings: The physician reviewer found that since fibromyalgia is now an FDA approved indication for Lyrica, and given that this patient has already been receiving Lyrica with significant benefit, continued use of the medication at standard doses (which typically range from 300mg to 450mg …”
And one the reviewer upheld
“A 64-year-old female enrollee has requested Ampligen for treatment of her chronic fatigue syndrome, myalgic encephalomyelitis and marked autonomic dysfunction. Findings: Two physician reviewers found that chronic fatigue syndrome may also be referred to as post-viral fatigue syndrome (PVFS, when the condition arises following a flu-like illness), myalgic encephalomyelitis (ME), or several other terms. The cause or origin of CFS …”
- 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 Immuno Disorders overturned?
In 19 California IMR decisions from 2003 to 2011, reviewers overturned 6 (31.6%). 18 were medical-necessity disputes, 1 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.