The ForwardHealth dossier provides a structured and uniform process for individuals to submit evidence related to the effectiveness and safety of a service under review for coverage. All ForwardHealth dossier requests must follow instructions in this submission packet. Evidence policy review submitted in other formats will not be accepted.
Individuals submitting evidence should understand that submission of information in the format recommended herein does not mean a product/service will be covered or approved for payment. Individuals submitting evidence must answer a series of questions related to the product/service and submitted evidence and comment on the net health impact of the service based on the evidence submitted. A dossier review submission that is incomplete or fails to follow this protocol will not be considered. All costs of dossier reviews must be borne by the submitter.
Once a dossier submission
is received, the Division of Medicaid Services (DMS) will evaluate the submitted evidence. Policy analysts will make recommendations and coverage will be determined by an assessment of the net health impact of the product/service as demonstrated by the available research evidence. DMS has no obligation to return submitted requests regardless of markings or statements of confidentiality contained in or on the request.
The following materials will be required, you may want to gather these items before you begin your submission.
- Peer reviewed literature/list of publications (randomized controlled trials; observational studies, prospective, retrospective, case series; expert panel, etc.)
- Product information sheet
- Supplemental data for published studies (subgroup analysis, additional outcomes, methods details)
- Unpublished studies
- Recommendation letters from credible users
- FDA approval letter
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