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Technology Assessment Program for Medical Devices
This program streamlines L&I's review process in new and emerging medical devices. This process is intended to maximize resources available locally and nationally. The expectation is to produce more timely, scientifically credible, and accurate policy decisions that will assist users in making uniform and consistent coverage decisions.
How do I request a new medical device review?
How are coverage decisions made for the technology assessment program?
Stage 1 - Should a complete technology assessment be done?
The first stage is to make a threshold decision as to whether or not the technology under review should be investigated under Stage 2. L&I staff from the Office of the Medical Director assemble and present a report for the Medical Director's review. The report will assist in making the decision as to whether or not the device should be evaluated further.
The Stage 1 process is not comprehensive, but enough so that an educated decision can be made on whether to commit further resources in research. Stage 1 uses information that is readily available. Detailed searches and analysis are reserved for Stage 2.
Factors that may be used in the report for the Medical Director's review:
- Why was this brought to the Office of the Medical Director for coverage consideration and what is the relative strength of that recommendation?
- What is the regulatory status of the device?
- What does the medical literature say about the device?
- How would L&I be impacted by the economic issues related to the device?
- What are other health insurers' position in relation to the device?
- What is the medical profession's opinion?
- How does it compare with established technologies for the same indication(s)?
- Are their additional considerations?
Stage 2 - What is the technology assessment protocol?
After the Medical Director has decided that the device merits further review, a complete technology assessment will be prepared. This is an expanded and more detailed study of the items enumerated in the Stage 1 process.
The coverage decision analysis and documentation will include the following:
- The rational and supporting documentation behind the decision to cover or not cover the assessed technology.
- Recommendations regarding the technology's appropriate indicated uses.
- The technical aspects of the assessed technology.
- Recommended payment guidelines for the technology.
See also the Evidence Review/Technology Assessments site.
