Non-FDA Approved Use for Orth/Musculoskeletal: 38.2% of denials overturned
In 68 California IMR decisions from 2003 to 2011, reviewers overturned 26 (38.2%). 63 were medical-necessity disputes, 5 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. | 11 | 54.5% | 38.2% |
| Prior therapies failedThe findings mention treatments that were tried without adequate response. | 9 | 77.8% | 38.2% |
| Published evidence citedThe findings refer to peer-reviewed or published evidence. | 8 | 25.0% | 38.2% |
| Records did not supportThe findings say the documentation did not show what was needed (usually an upheld denial). | 7 | 14.3% | 38.2% |
| Alternatives contraindicatedThe findings mention a contraindication to the plan's preferred option. | 3 | 33.3% | 38.2% |
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 54-year-old male enrollee has requested Lyrica for treatment of his pain. Findings: The physician reviewer found that the treatment of neuropathic pain of any etiology can be managed with membrane stabilizing agents such as Lyrica and Neurontin. These medications are generally part of first-line therapy and are an integral part of a comprehensive management strategy for difficult to control …”
“A 35-year-old female enrollee has requested Zometa (zoledronic acid) infusions for treatment of her medical condition. Findings: The physician reviewer found that zoledronic acid is indicated for the reduction of skeletal related events in patients with metastatic solid tumors and multiple myeloma. It is also indicated for the treatment of osteoporosis. This patient has two indications for treatment with zoledronic …”
“A 64-year-old female enrollee has requested Hyalgan injections for treatment of her osteoarthritis and severe degeneration of both shoulders. Findings: The physician reviewer found that although the use of Hyalgan would be an off-label indication for use in this patient, she has documented severe degeneration in both shoulders. In addition, she has already undergone surgical intervention but continues to experience …”
And one the reviewer upheld
“A 62-year-old female enrollee has requested Lyrica for treatment of her pain. Findings: The physician reviewer found that there is a lack of clinical trial evidence supporting the use of antiepileptic medications such as Lyrica for chronic low back pain (Chang, et al.). Per Eisenberg, et al., there is a need for large-scale randomized controlled trials on the efficacy 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 Orth/Musculoskeletal overturned?
In 68 California IMR decisions from 2003 to 2011, reviewers overturned 26 (38.2%). 63 were medical-necessity disputes, 5 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.