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Medical Device Reimbursement in England, UK.

Identification and application for OPCS codes, England's Diagnosis-Related Groups (HRGs) and the NICE medical technologies evaluation programme (MTEP).

Reimbursement Landscape in England, UK

The purpose of this step is to understand the current reimbursement environment in England, relevant for your medical device. To do so, we will:

  • Clarify the relevant type of coding systems, coverage policies issued by the National Institute for Health and Care Excellence (NICE) or local clinical commissioning groups (CCGs, formerly PCTs), limitations and guidelines, relevant type of payment mechanisms, such as Healthcare Resource Groups (HRG) or block contracts, applicable for the specific device or to any comparable products.
  • Locate any specific reimbursement mechanisms that could be utilized by the device, as-is, or recommend on whether new mechanisms will have to be developed and if so, which mechanisms, for example, a new code or an application for NICE medical technologies evaluation programme (MTEP).
  • Identify the main decision makers, lay out the typical path towards obtaining national (NHS) or local (CCG) reimbursement, including milestones and typical timelines and provide an initial reimbursement strategy for the device in England.

Reimbursement Planning for England's Decision Makers

According to the conclusions in the Reimbursement Landscape, we devise the plan for developing the required evidence for England's decision makers, such as the National Institute for Health and Care Excellence (NICE), local clinical commissioning groups (CCGs, formerly PCTs) the Medical Technologies Advisory Committee (MTAC) or NHS England. This includes the development of:

  • Value Story: Puts forward the claims for clinical and economic benefits associated with the use of the new device in the eyes of the relevant decision makers and would serve as the basis for the Economic Model.
  • Economic Model: Highlights the economic benefits of the new device from the perspective of UK decision makers. May identify specific outcomes data that should be added to future clinical study protocols.
  • Clinical Data: Recommendations for adjustments and modifications of any planned clinical studies in order to generate the required reimbursement-related evidence for decision makers.
  • Decision Makers' Feedback: Conduct interviews with the identified decision makers to obtain their feedback regarding the developed value story, the economic model and the reimbursement aspects of the planned clinical study.

Implementation

Depending upon the existence, or the lack of, applicable reimbursement mechanisms (as identified in the Reimbursement Landscape step), we will conduct the following activities:

  • Billing Guide: Develop a set of instructions guiding physicians and other healthcare providers how to obtain reimbursement following the use of the new device.
  • Reimbursement Applications: Work with the relevant medical societies to apply for new reimbursement mechanisms, on a local level by each of the clinical commissioning groups (CCGs, formerly PCTs) or on a national level by approaching the National Institute for Health and Care Excellence (NICE) and its medical technologies evaluation programme (MTEP).
  • Pilot Projects: Initiate pilot projects with local CCGs.
  • Other Funding Options: Apply for other or interim funding options, such as individual funding requests (IFRs).

Flat fees, concrete timelines, and support through your entire reimbursement process

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