In consultation with your Medicare-enrolled doctor or other health care provider, you may be prescribed use of durable medical equipment (DME) in your home. Medical insurance will cover medically necessary DME, which includes electric wheelchairs, mobility scooters, and power lift recliners.
Pride Mobility® is proud to offer a robust lineup of each of these products, but you may be wondering about the process through which these products go to become “reimbursable” through insurance, and what separates certain products from others.
What is an FDA Class II Medical Device?
You may notice that nearly all Pride products are classified as “FDA Class II Medical Device”. The U.S. Food & Drug Administration defines Class II devices as those “for which special controls, combined with general controls, are necessary to provide reasonable assurance of safety and effectiveness.”1
The manufacturer, when researching and developing a new product, must go through the FDA and meet certain criteria if it wishes to have the product classified as a medical device. This is an important step toward making a product reimbursable through insurance.
What is an HCPCS code?
The Healthcare Common Procedure Coding System (HCPCS) is a collection of codes that represent procedures, supplies, products, and services which may be provided to Medicare beneficiaries and to individuals enrolled in private health insurance programs.2 These are standardized codes used to bill insurance for DME and are part of a numeric coding system maintained by the American Medical Association.
These HCPCS codes represent medical procedures to Medicare, Medicaid, and several other third-party payers. While there are many categories, you will find Pride products classified under those that begin with “E” or “K”, as these both contain DME.
How does a product receive an HCPCS code?
In order to cover power mobility devices, Medicare requires that the device have an official code verification through the PDAC, the Medicare Pricing Data Analysis and Coding contractor who assigns HCPCS codes. This verification ensures that the products that beneficiaries are receiving are of a certain standard and quality.
The PDAC compiles testing results to determine safety and performance and considers characteristics, power options, weight capacity, seating, and much more before assigning an HCPCS code.
Following this review, PDAC could: confirm the requested code, deny the requested code, and/or come back with a different suggested code for the product. If a code is confirmed, the product is officially classified and marketed as such, giving a clear signal to Medicare and other health care providers that the product may be covered by insurance.
Some Pride products, which are considered medical devices, have not received official PDAC code verification. These items are billed with HCPCS code K0899 and are not covered by Medicare. They may be reimbursed by other funding sources that do not require official PDAC code verification for coverage or they may be available as a retail only purchase.
Pride also offers mobility products that are considered non-medical and are not intended to assist, treat, diagnose, or alleviate any medical condition or disability. These products are also available and may be purchased directly from a Pride retailer.
If a Pride product has an official code verification, you can be sure it’s undergone substantial testing and that it’s met stringent guidelines and parameters to receive such a code. Independent testing is required, and Medicare will expect that the DME will last five years from the time you receive it. That’s considered the reasonable useful lifetime of a product.
If you have questions about your mobility options and are considering a Pride Mobility electric wheelchair, mobility scooter, or power lift recliner, check out our step-by-step consumer guide to Medicare coverage.