Non-FDA Approved Use for Mental Disorder: 38.9% of denials overturned
In 54 California IMR decisions from 2003 to 2009, reviewers overturned 21 (38.9%). 53 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. | 22 | 27.3% | 38.9% |
| Records did not supportThe findings say the documentation did not show what was needed (usually an upheld denial). | 5 | 0.0% | 38.9% |
| Published evidence citedThe findings refer to peer-reviewed or published evidence. | 4 | 75.0% | 38.9% |
| Prior therapies failedThe findings mention treatments that were tried without adequate response. | 3 | 66.7% | 38.9% |
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 12-year-old male enrollee has requested Vyvanse 80 mg/day for the treatment of the enrollee’s attention deficit hyperactivity disorder (ADHD). Findings: The physician reviewer found that the concept that this patient may be a rapid metabolizer of his medications is a well-documented concept in the literature, especially for his age group as prepubescent children have efficient livers …”
“The parent of a 16-year-old male enrollee has requested Vyvanse for the treatment of the enrollee’s attention deficit/hyperactivity disorder (ADHD). Findings: The physician reviewer found that the Health Plan’s criteria for this medication requires that the patient is between the ages of 6 and 12 years, has had an unsatisfactory response to a medication in the amphetamine and methylphenidate class …”
“The parent of a 16-year-old male enrollee has for Vyvanse for treatment of the enrollee’s attention deficit/hyperactivity disorder (ADHD). Findings: The physician reviewer found that the FDA has approved Vyvanse for the treatment of ADHD. The age range specified in the package insert limits the age range that the manufacturer can use in advertising the product. The FDA does not …”
And one the reviewer upheld
“A 35-year-old female enrollee has requested Provigil for the treatment of her depression and anxiety with excessive sleepiness. Findings: The physician reviewer found that there is very little supporting documentation of how Provigil has necessarily added to the patient’s welfare. From what little can be discerned, she still appears fatigued and irritable despite taking Paxil and Provigil. The dosage of …”
- 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 Mental Disorder overturned?
In 54 California IMR decisions from 2003 to 2009, reviewers overturned 21 (38.9%). 53 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.