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Medical Device Reimbursement in the USA.

Identification and application for CPT and HCPCS codes, Medicare Severity Diagnosis Related Groups (MS-DRGs) and hospital outpatient Ambulatory Payment Classifications (APC) codes.

Reimbursement Landscape in the USA

The purpose of this step is to understand the current reimbursement environment in the USA, relevant for your medical device, and develop an initial reimbursement strategy. To do so, we will:

  • Clarify the relevant type of procedure coding systems (CPT, HCPCS or ICD-10-PCS), identify relevant coverage policies by public or commercial payers, relevant type of payment mechanisms (MS-DRG, APC and different fee-for-service fee schedules) and payment rates, 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 (e.g., a new CPT or HCPCS code, a new coverage policy, or a modified payment rate).
  • Identify the main decision makers, lay out the typical path towards obtaining public (Medicare, Medicaid) or commercial payer reimbursement, including milestones and typical timelines and provide an initial reimbursement strategy for the device in the USA.

Reimbursement Planning for US Decision Makers

According to the conclusions in the Reimbursement Landscape, we devise the plan for developing the required evidence for US decision makers, such as the Centers for Medicare & Medicaid Services (CMS), the American Medical Association (AMA) or health technology assessment (HTA) entities such as the Blue Cross and Blue Shield Association's Technology Evaluation Center (TEC). 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 (healthcare providers, public and commercial payers) and would serve as the basis for the Economic Model.
  • Economic Model: Highlights the economic benefits of the new device from the perspective of US 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 US decision makers, utilizing Mediclever's network of local clinicians, payer representatives and other stakeholders, to obtain their feedback regarding the developed value story, the economic model and the reimbursement aspects of the planned clinical study.


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, such as CPT, HCPCS or ICD-10-PCS codes and inclusion in the relevant public/commercial payer's coverage policies.
  • Pilot Projects: Initiate pilot projects with local payers or Medicare contractors.
  • Other Funding Options: Apply for other or interim funding options such as New Technology Add-On Payment and Pass-Through Payments under the hospital outpatient prospective payment system (OPPS).

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

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