Non-FDA Approved Use for Infectious Disease: 45.5% of denials overturned
In 11 California IMR decisions from 2003 to 2009, reviewers overturned 5 (45.5%). 10 were medical-necessity disputes, 1 experimental/investigational.
What the findings mention
From recent overturned decisions
“A 51-year-old female enrollee has requested for Rituxan (rituximab) therapy for treatment of her cryoglobulinemia. Findings: The physician reviewer found that mixed cryoglobulinemia is an immune complex mediated disease involving small to medium vessel vasculitis. It is associated with HCV in many instances. This disease can affect vital organs including the kidney, liver and heart. Early treatment often involves a …”
“A 59-year-old male enrollee has requested Rituxan (rituximab) for the treatment of his cryoglobinemia. Findings: Three physician reviewers found that cryoglobulinemia is relatively rare, and it is unlikely that a large, controlled clinical trial will be forthcoming anytime soon. For a patient such as this patient, treatment options include immunosuppressive therapy such as cyclophosphamide or cyclosporine, or rituximab. Rituximab is …”
“The patient is a 48-year-old male with onychomycosis confirmed by a April 2006 fungal culture which was positive for alternaria species. His symptoms include crumbling and deterioration of the toenails. Liver function tests from June 2006 were within normal limits. The request for authorization of Lamisil from the enrollee’s provider was denied by the Health Plan based upon a determination …”
And one the reviewer upheld
“A 29-year-old female enrollee has requested Alinia for the treatment of her toxoplasma gondii and bacterial overgrowth. Findings: The physician reviewer found that Alinia was prescribed in this case to treat toxoplasma positive serology (toxoplasma gondii) and bacterial overgrowth as indicated by the provider. A review of the peer-reviewed scientific literature revealed no evidence supporting the use of Alinia for …”
- 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 Infectious Disease overturned?
In 11 California IMR decisions from 2003 to 2009, reviewers overturned 5 (45.5%). 10 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.