The regulation of businesses providing Durable Medical Equipment (DME) or Home Medical Equipment (HME) is dependent upon the types of equipment, as well as the jurisdiction. Since the term DME covers a wide array of devices, from crutches to catheters to wheelchairs to blood glucose monitors, it may not always be clear for businesses whether they must be licensed in a particular state. Furthermore, additional permitting may be required for certain types of equipment (e.g., a Pharmacy License for oxygen-related devices). DME supplier are governed by stringent federal and state laws, particularly those that participate in the Medicare/Medicaid program. Initially, if a license is determined to be required, a DME company must obtain an “in-state” or a “resident” license. This generally requires an extensive application, varying fees, proof of insurance, and an inspection, which is usually scheduled upon approval of the application. If the company wishes to expand into another state, it must obtain an “out-of-state” or a “non-resident” license in that state. This process is more of the same, but also may require verification that the business currently holds a resident license (or proof that a license is not required) in the home state.
Medical practitioners and medical service-providing organizations that want to be able to bill the Medicare system for supplying Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) need to undergo a rigorous process. The procedure is handled by the Center for Medicare and Medicaid Services (CMS). While there are exemptions, it is applicable to medical practitioners who want to act as suppliers Since the beginning of 2019, dentists providing DMEPOS to patients are also required to undergo an accreditation process and meet relevant requirements.
DME providers include DME companies, home health agencies, physicians, and other practitioners. The fact that you are a licensed home health agency or physician/practitioner does not exempt you from DME licensure. The State Board of Pharmacy of the Department of Health generally issues licenses.
Step-by-Step Guide for How to become a DME supplier for Medicare
Obtaining a National Provider Identifier Number
While this is not a part of the accreditation itself, getting a National Provider Identifier (NPI) number is necessary for meeting the DME license requirements. Existing providers typically have the number already, as it is required by the CMS and commercial healthcare insurers.
To obtain the National Provider Identifier (NPI) number, you’ll have to go through the process with the National Plan and Provider Enumeration System (NPPES). The NPI is a 10-digit number that will be used as your identification in the system for all types of administrative and billing transactions. We will discuss in detail on how to get NPI in our DME blog series.
Meeting Supplier and Quality Standards
Becoming an accredited DMEPOS supplier with the CMS entails satisfying a set of supplier standards. Prosthetics, Orthotics and Supplies standards handbook is a good starting point. The book is available as a free download on the CMS website. They are detailed in 42 Code of Federal Regulations (CFR) 424.57(c). By adhering with them, you ensure your Medicare billing privileges through the National Supplier Clearinghouse (NSC).
The first section covers the administration, financial management, human resources management, consumer services, performance management, product safety, and information management standards. The second lays out intake and assessment, delivery and set-up, training and instruction, and patient follow-up requirements.
Getting Accreditation with Approved Accreditation Organization
The accreditation process is the main answer to the question how to become a DME supplier for Medicare. You have to select one of the 10 approved by the CMS accreditation organizations and get acquainted with their procedure. Information about each agency is available on the CMS website. Regardless of which agency you choose, the licensing steps are the same. Then you have to fill in an official application with the respective organization. It will use the Quality Standards to assess your suitability and will make an unannounced on-site survey too.
The accreditation can take up to nine months from the time of your application. Once you have obtained it, you have to undergo Medicare enrollment with the CMS. Institutional providers have to use the CMS-855A Form, while DMEPOS suppliers have to complete the CMS-855S Form. Each license is valid for three years and there are no annual fees.
Preparing for Application
During the pre-application phase, you will work with the accreditation agency to make sure your company meets CMS quality standards. Following an intensive review, the agency will determine whether you need to make changes, such as updating or creating new policies and procedures, conducting employee training or modifying existing services. After identifying and implementing any necessary changes, it’s time to submit an application containing detailed information about your business, a preliminary evidence report issued by the accreditation agency, a signed accreditation agreement and the required deposit.
On-Site Inspection
While you can’t schedule a specific date for an on-site inspection, you can identify as many as 10 black-out dates. A surveyor from the accreditation agency will tour your facility and may interview one or more employees to verify the information in your application and the preliminary evidence report. The surveyor will also review employee and patient records, financial statements and billing records, service contracts, risk management standards, and your policies and procedures manual. It will take about two months from the inspection date to get your license provided all goes well.
Getting DMEPOS Surety Bond
One of the main DME accreditation costs is connected with meeting the bonding requirement set in the enrolment process. You have to provide a $50,000 surety bond to the CMS. This amount is necessary for each NPI you have and want to use. Thus, you may need a larger bond amount if you have numerous practice locations as an organizational supplier.
In order to get bonded, you have to pay a bond premium, which is a fraction of the required amount. In case your finances are in good shape, the rates are usually between 1% and 5%. This means that if you have to provide a $50,000 surety bond, your costs would be in the range of $500 to $2,500.
FAQs: Durable Medical Equipment (DME) and Home Medical Equipment (HME)
1. What is Durable Medical Equipment (DME)?
Durable Medical Equipment (DME) includes a wide range of devices like crutches, wheelchairs, and blood glucose monitors that assist patients in daily life. These devices are typically reusable and support medical care at home.
2. Do I need a license to provide DME?
Yes, DME suppliers need to be licensed, and the licensing requirements vary by state. In addition, you may need specific permits for certain types of equipment, such as a Pharmacy License for oxygen-related devices.
3. How do I become a DME supplier for Medicare?
To become a DME supplier for Medicare, you must go through a rigorous accreditation process with a CMS-approved organization, obtain a National Provider Identifier (NPI) number, and meet supplier and quality standards.
4. What is an NPI number, and do I need one to supply DME?
An NPI (National Provider Identifier) number is a unique 10-digit identifier used for administrative and billing transactions. It is required for DME suppliers to bill Medicare and other healthcare insurers.
5. What is the CMS-855S form used for?
The CMS-855S form is used by DMEPOS suppliers to enroll with Medicare. This form allows suppliers to be recognized by Medicare and bill for their services.
6. What is the purpose of a DMEPOS surety bond?
A $50,000 DMEPOS surety bond is required by CMS to ensure that DME suppliers comply with Medicare regulations. It acts as financial protection in case of non-compliance.
7. How long does the DME accreditation process take?
The accreditation process can take up to nine months from the time you submit your application. It includes an on-site inspection and a thorough review of your business.
8. What happens during an on-site inspection for DME accreditation?
During an on-site inspection, a surveyor will tour your facility, review records, and verify that your company meets CMS standards. The inspection usually takes about two months to process.
9. What are the DME supplier standards?
DME suppliers must meet standards in areas such as administration, financial management, product safety, patient services, and staff training. These are outlined in the 42 CFR 424.57(c) regulation.
10. Where can I find official guidelines for DME providers?
Official DME guidelines can be found on the CMS website and the State Board of Pharmacy, which generally issues the licenses. Following these guidelines ensures compliance with both federal and state laws.