Non-FDA Approved Use for Digestive System/ GI: 41.4% of denials overturned
In 29 California IMR decisions from 2003 to 2009, reviewers overturned 12 (41.4%). 27 were medical-necessity disputes, 2 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. | 5 | 60.0% | 41.4% |
| Published evidence citedThe findings refer to peer-reviewed or published evidence. | 4 | 50.0% | 41.4% |
| Prior therapies failedThe findings mention treatments that were tried without adequate response. | 3 | 66.7% | 41.4% |
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 13-year-old male enrollee has requested Leukine for treatment of Crohn’s disease. Findings: The physician reviewer found that Leukine is designated for the treatment of neutropenia. Due to neutropenia the patient cannot be treated with either immunosuppressive agents such as 6-MP, Imuran or Remicade. As such, it is prudent and appropriate to use Leukine in this setting, …”
“A 59-year-old male enrollee has requested for Xifaxan for treatment of his Crohn’s disease. Findings: The physician reviewer found that although Xifaxan is not FDA approved for the treatment of Crohn’s disease, a review of the literature indicates it can be useful for patients with this condition. It is thought that bacterial overgrowth contributes to exacerbations of Crohn’s disease. Like …”
“A 23-year-old male enrollee has requested the medication Xifaxan for treatment of his irritable bowel syndrome. Findings: The physician reviewer found that although the Food and Drug Administration’s approval for this medication is for traveler’s diarrhea, there are many peer-reviewed articles supporting the usefulness of Xifaxan in the setting of IBS. A study by Pimentel, et. al. concluded Xifaxan improves …”
And one the reviewer upheld
“A 47-year-old female enrollee has requested Actiq for the treatment of her pain. Findings: The physician reviewer found that Actiq is approved by the Food and Drug Administration for use in cancer pain patients, and the package insert specifically states its use is to be limited to cancer pain only. There are no randomized controlled trials of this medication in …”
- 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 Digestive System/ GI overturned?
In 29 California IMR decisions from 2003 to 2009, reviewers overturned 12 (41.4%). 27 were medical-necessity disputes, 2 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.