Non-FDA Approved Use for OB-GYN/ Pregnancy: 14.3% of denials overturned
In 7 California IMR decisions from 2005 to 2011, reviewers overturned 1 (14.3%). 5 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. | 3 | 0.0% | 14.3% |
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 51-year-old female enrollee has requested Lyrica for treatment of her pudendal nerve entrapment. Findings: Two physician reviewers found that the literature details anti-convulsant membrane stabilizer medications as being the first line therapy in the standard of care for peripheral neuropathy and neuropathic pain caused by many factors. The Health Plan is denying coverage for the medication Lyrica because the …”
And one the reviewer upheld
“A 53-year-old female enrollee has requested compounded progesterone powder with compounded Tri-Est for treatment of her postmenopausal. Findings: Three physician reviewers found that Tri-Est is a combination of estriol, estradiol and estrone. In 2008, the Food and Drug Administration (FDA) stated that estriol is not a component of an FDA-approved drug and has not been proven safe and effective 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 OB-GYN/ Pregnancy overturned?
In 7 California IMR decisions from 2005 to 2011, reviewers overturned 1 (14.3%). 5 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.