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Oncotype DX Assay for Cancer: 47.5% of denials overturned

In 61 California IMR decisions from 2007 to 2019, reviewers overturned 29 (47.5%). 7 were medical-necessity disputes, 54 experimental/investigational.

What the findings mention

What the findings mentionDecisionsOverturnedAll decisions here
Published evidence citedThe findings refer to peer-reviewed or published evidence.2045.0%47.5%
Experimental or investigationalThe findings discuss whether the treatment is experimental.1020.0%47.5%
Guidelines or criteria citedThe findings cite guidelines, criteria or a standard of care.933.3%47.5%

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 reimbursement for genetic testing, Oncotype DX Genomic Prostate Score. Findings: Three physician reviewers found that per the National Comprehensive Cancer Network (NCCN), men with low or favorable intermediate risk prostate cancer may consider Oncotype DX Genomic Prostate Score. Retrospective studies have shown that molecular assays performed on prostate biopsy or radical …

Reviewer findings, overturned decision · Experimental/Investigational · 2019 · Source: California DMHC IMR determinations (CHHS Open Data), reference EI19-31322

An enrollee has requested reimbursement for the OncotypeDX Prostate Assay. There currently are three major therapeutic strategies to the management of localized prostate cancer: surgical prostatectomy; various forms of radiation; or surveillance only with no specific cancer treatment. Clinical stage, PSA and biopsy pathology determine an individual patient’s risk category. Applying the current National Comprehensive Cancer Network (NCCN) guidelines, he …

Reviewer findings, overturned decision · Experimental/Investigational · 2019 · Source: California DMHC IMR determinations (CHHS Open Data), reference EI19-31034

Nature of Statutory Criteria/Case Summary: At issue is whether Oncotype DX Prostate Cancer Assay that was performed was likely to have been more beneficial for the evaluation of the patient’s condition than any available standard therapy. A review of the records indicates that the patient presented for an evaluation of lower urinary tract symptoms and prostate cancer.Findings: Three physician reviewers …

Reviewer findings, overturned decision · Experimental/Investigational · 2019 · Source: California DMHC IMR determinations (CHHS Open Data), reference EI19-30744

And one the reviewer upheld

Nature of Statutory Criteria/Case Summary: A patient requested reimbursement for gene testing services (Oncotype DX) that were performed. The Health Plan has denied the services at issue as investigational for evaluation of the enrollee’s colon cancer. Findings: Two physician reviewers found that it has not been established if molecular markers are useful in treatment determination and prognosis in patients with …

Reviewer findings, overturned decision · Experimental/Investigational · 2019 · Source: California DMHC IMR determinations (CHHS Open Data), reference EI19-30653
Read these numbers carefully
  • 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 Oncotype DX Assay denials for Cancer overturned?

In 61 California IMR decisions from 2007 to 2019, reviewers overturned 29 (47.5%). 7 were medical-necessity disputes, 54 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.

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Denied for this?

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.