New companies would simply put together mock ups of what an actual patient file was going to look like. The mock patient files were required to meet all applicable education and delivery standards with documentation of training, education, delivery, and customer service provided. Patient rights, warranty info, financial responsibilities, home safety assessments (when appropriate) and any other documentation were expected to be present in these files. And the staff that showed the files was expected to be conversant in how the equipment was delivered, set up, explained, and how the paperwork was filled out. Often, the surveyor would ask the staff member to pretend they were setting up equipment and educating a patient and his or her caregivers on the surveyor themselves! These scenarios and acting out were part of the process and a fairly effective way to evaluate the knowledge of the staff regarding not only the equipment, but also the paperwork flow and documentation requirements.
Along came December of 2025 and new, updated guidance from CMS set forth the expectation that mock patient files were not acceptable and that the company had to have actually provided care, treatment, and service to five REAL patient/customers. Frankly, the mock files and role-playing equipment set up procedures had limitations. Surveyors might interview the staff, peppering their questions with “what ifs”, but there’s nothing like the real thing to see how competent and effective the staff and processes are in the real world.
So, the new rule went into place whereby a new organization is required to actually provide care, service, and equipment to REAL patient/customers. Five is the typical number, which allows for a cross section of outcomes and experiences to help the accrediting body evaluate a company’s ability to provide these services. Along with the rule came some challenges. Turns out, it’s a catch-22 trying to find customers. You can’t bill for the services and products because you’re not accredited and don’t have a Medicare provider number. But you can’t get accredited –a condition of participation to obtain a billing number—until you service some customers. New companies and new branches struggle finding these patient/customers. Let’s look at some strategies to comply with this challenging requirement.
How to Fish for Patient/Customers:
You’ll want a good cross section of equipment services that covers your equipment list and scope of services. For instance, a full line DME offering complicated respiratory equipment such as oxygen and ventilators, cannot simply provide blood pressure cuffs or walkers. There’s no hard-fast rule on percentages or numbers, but if you are rounding up five patient/customers to service, make sure you cover the more complex equipment in at least one patient file.
Check with payer sources and/or your billing service or billing software support to see about billing for services after you are accredited. Most payer sources have strict regulations regarding how far back you can bill and many forbid you from billing dates prior to accreditation. But it is worth checking to see if that is a possibility with some insurances.
Also, it’s worth checking up front: while most insurances follow Medicare policies regarding un-accredited providers, it is still possible (though unlikely, to be frank) to find entities that will pay you before you are accredited. This might be a long shot, but it would lessen the financial burden of providing free care on your company.
Finally, keep this challenge in perspective. While it is certainly another hurdle in establishing a DME business, it is being implemented across the board and fairly. Thus, ALL new organizations must jump through the same hoops in an effort to open a DME. Once your organization achieves accreditation and gets properly licensed, you’ll be a member of an elite group of business owners providing equipment and services to a customer base that is growing exponentially every day.