Investigational Tx denials: 44.1% overturned by independent reviewers
In 145 California IMR decisions from 2001 to 2019, reviewers overturned the plan 64 times (44.1%). Denials reach IMR only when a member appeals all the way; read the caveats below before generalising.
By diagnosis
| Diagnosis category | Decisions | Overturned | Last 5 years |
|---|---|---|---|
| Cancer | 137 | 43.8% | — |
What the findings mention
| What the findings mention | Decisions | Overturned | All decisions here |
|---|---|---|---|
| Experimental or investigationalThe findings discuss whether the treatment is experimental. | 49 | 38.8% | 44.1% |
| Published evidence citedThe findings refer to peer-reviewed or published evidence. | 38 | 39.5% | 44.1% |
| Guidelines or criteria citedThe findings cite guidelines, criteria or a standard of care. | 13 | 46.2% | 44.1% |
| FDA approval or off-label use discussedThe findings discuss the FDA label status of the treatment. | 6 | 66.7% | 44.1% |
| Step therapy or fail-firstThe findings mention a fail-first requirement. | 4 | 50.0% | 44.1% |
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
“Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Mekinist (trametinib) 0.5 mg tablets. The submitted documentation supports the medical necessity of the requested medication. Approximately 50 percent of cases of Erdheim-Chester disease (ECD) do not harbor a BRAF mutation, but will have NRAS, PIK3CA, or mutations of the RAS-PI3K-AKT signaling pathway, providing rationale for targeting …”
“Nature of Statutory Criteria/Case Summary: A enrollee has requested reimbursement for the OncotypeDx Breast Cancer Assay testing. The OncotypeDx Breast Cancer Assay recurrence score can be considered in select patients with one to three involved ipsilateral axillary lymph nodes to guide the addition of combination chemotherapy to standard hormone therapy. A retrospective analysis of a prospective randomized trial suggests that …”
“Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the immunology test rendered. The Health Plan has denied this request as investigational for treatment and evaluation of the enrollee’s condition. Findings: The immune cell function assay testing, also known as ImmuKnow is considered beneficial and clinically relevant in the case of this patient’s condition. The patient is status …”
- 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 Investigational Tx denials overturned?
In 145 California IMR decisions from 2001 to 2019, reviewers overturned the plan 64 times (44.1%).
What did the reviewers' findings mention in overturned cases?
The table on this page counts keyword matches in the findings: prior therapies tried, contraindications, guidelines cited, published evidence, whether the records supported the request. They describe what the findings say, not why the case was decided.
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 the reasoning is the same kind: criteria, documentation and alternatives. Use the findings as a guide to what to document.
Related: California appeal rights · California external-review reversal rate · The levers library · CSV
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.