Many doctors have asked me if they need a special license to bill DME units like a TENS unit. The short answer is – YES, you do need a license. Most insurance companies are starting to catch on to this special license and they are denying DME (Durable Medical Equipment) CPT codes. Check your Explanation of Benefits from the different carriers. You will notice that you are not getting reimbursed by many insurance companies.
See the law on needing the DME license. The purpose of this law is to enforce basic standards that will ensure quality home medical equipment, products, and services. Know what the FDA Food Drug and Cosmetic Act classifies a DME.
There are fees associated with getting the license. The licensing fee is about $300 but the amount of paperwork necessary to get the license might not be worth it for some people.
And if you don’t want to get the DME license just note that there is a maximum administrative penalty of up to $5,000 per TENS unit sold. It’s also a second degree misdemeanor for the first violation and a first degree misdemeanor for second and subsequent violations.
For those of you who don’t like what you are hearing take a look at some other sources:
The FCA