How Does a Product Receive an HCPCS Code and Become Reimbursable? – Med Mart

Understanding How Medical Equipment Qualifies for Insurance Coverage

If your doctor has recommended durable medical equipment (DME) like a mobility scooter, power wheelchair, or lift recliner, you may be wondering how these products become eligible for insurance reimbursement—including through Medicare.

The process involves multiple steps, from FDA classification to approval by Medicare’s coding system. Here's a clear overview of how it works.

What Is an FDA Class II Medical Device?

Many Pride Mobility® products are classified as FDA Class II Medical Devices. This designation means the product:

Has been reviewed by the FDA
Meets safety and effectiveness requirements
Is intended for medical use in the home

Class II devices are considered more complex than basic medical supplies and require special controls to ensure safety. This classification is often the first step toward making a product eligible for insurance coverage.

What Is an HCPCS Code?

The Healthcare Common Procedure Coding System (HCPCS) is used by Medicare and other insurers to identify and reimburse for medical procedures, services, and equipment.

These are standardized billing codes
HCPCS codes for durable medical equipment typically begin with “E” or “K”
Insurance companies—including Medicare—use these codes to decide what products are covered and how much they will reimburse

Who Assigns These Codes?

HCPCS codes for DME are assigned by PDAC (Pricing, Data Analysis, and Coding contractor), which works with the Centers for Medicare & Medicaid Services (CMS). PDAC evaluates:

Product safety and construction
Electrical and power features
Weight capacity
Seating system
Overall design and intended use

This review process helps ensure that all reimbursable equipment meets consistent medical standards.

How Does a Product Get a Code?

Product is Developed by the Manufacturer
The company designs the equipment and gathers documentation on its use, safety, and purpose.
FDA Classification
If applicable, the product is reviewed and classified as a Class II Medical Device.
PDAC Submission
The manufacturer submits the product to PDAC with technical details, test results, and design specifications.
PDAC Review and Decision
PDAC evaluates the product and either:
- Approves the requested HCPCS code
- Assigns a different code
- Denies the request

Once approved, the product can be marketed with a specific reimbursable HCPCS code, and healthcare providers will know the product is eligible for insurance or Medicare coverage.

Why Does This Matter?

If you're planning to use insurance or Medicare to pay for a product like a scooter or power chair, it must:

Be prescribed by a Medicare-enrolled physician
Be medically necessary for use in your home
Have a verified HCPCS code

Not all models qualify, even within the same brand. That’s why it’s important to check with your doctor, insurance provider, or contact our support team to verify eligibility.

Have Questions?

Our team is here to help you understand what equipment is reimbursable and what options you have if you’re paying out of pocket. Call us at 888-413-8994 to speak with a product specialist.

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