US Medical Device Reimbursement: Strategy, Coding & Coverage

Medical Device Reimbursement Landscape in the USA

The purpose of this step is to understand the current reimbursement environment in the USA. Learn more about reimbursement planning and implementation pathways.

• 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 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 (e.g., a new CPT or HCPCS code, a new coverage policy, or a modified payment rate).

Reimbursement Planning for US Medical Device Decision Makers

Based on the Reimbursement Landscape, we develop the plan for generating the required evidence for US decision makers, including CMS, AMA, or HTA entities such as the Blue Cross and Blue Shield Association's Technology Evaluation Center (TEC). This includes:

• Value Story: Clinical and economic claims supporting the device, forming the basis for the economic model.
• Economic Model: Highlights economic benefits from the US perspective; may identify specific outcomes for future clinical studies.
• Clinical Data: Recommendations to modify planned clinical studies to generate reimbursement-related evidence.

Implementation

Depending on the existence of applicable reimbursement mechanisms, we conduct:

• Billing Guide: Instructions guiding providers on how to obtain reimbursement for the new device.
• Reimbursement Applications: Apply for new CPT, HCPCS, or ICD-10-PCS codes and inclusion in coverage policies.
• Pilot Projects: Initiate pilot projects with local payers or Medicare contractors.
• Other Funding Options: Apply for interim funding options such as New Technology Add-On Payments and Pass-Through Payments under OPPS.

Key Questions About Medical Device Reimbursement in the USA

How long does medical device reimbursement take in the USA?

Timelines depend on the reimbursement pathway, the complexity of coding, and payer review processes. Typically ranges from 6 to 24 months.

Which reimbursement pathways exist in the USA?

Medical devices may be reimbursed via CPT or HCPCS codes, MS-DRGs, APCs, and coverage policies from Medicare, Medicaid, or commercial payers.

What is the difference between CPT and HCPCS codes for medical devices?

CPT codes primarily describe physician services and procedures, while HCPCS Level II codes are used for medical devices, supplies, and non-physician services. Medical devices used in outpatient or physician office settings are often billed using HCPCS codes, whereas CPT codes may apply when the device is integral to a procedure.

How do medical devices obtain Medicare coverage in the USA?

Medicare coverage for medical devices may be established through National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), or case-by-case coverage decisions. Coverage depends on clinical evidence demonstrating medical necessity and alignment with Medicare benefit categories.

Can reimbursement be pursued before FDA clearance?

In some cases, reimbursement planning activities can begin before FDA clearance, including coding strategy development and evidence planning. However, formal Medicare or commercial payer coverage and payment generally require FDA clearance or approval before reimbursement can be implemented.

View all medical device reimbursement FAQs

Why Mediclever for Medical Device Reimbursement in the USA?

Mediclever is a specialized reimbursement consultancy supporting medical device manufacturers in the USA with evidence generation, coding, and market access execution. Our team has supported reimbursement strategies across multiple therapeutic areas and payer systems.