DME License in Florida
The durable medical equipment (DME) business represents a substantial and growing global market, supported in part by an aging population and increasing demand for long-term and home-based care. Florida also has a large potential customer base for home medical equipment, with more than one-fifth of the state’s population age 65 or older. Not surprisingly, there are many who are interested in starting their own DME business to capitalize on these opportunities. However, there are several things a business owner must do first in order to legally operate their DME business in Florida.
Key Takeaways About Florida DME Licensing
- Florida businesses that provide certain home medical equipment and related services may need a Home Medical Equipment (HME) license from the Agency for Health Care Administration (AHCA).
- Whether a license is required depends on factors such as the equipment provided, services offered, customers served, and structure of the business. Cash-pay or retail sales do not automatically exempt a business from Florida HME licensing requirements.
- Licensing requirements may include liability insurance, an appropriate physical location, financial documentation, background screening, emergency planning, and additional requirements for certain out-of-state providers.
- Businesses seeking licensure generally begin with AHCA Form 3110-1005 and may need additional forms and supporting documentation depending on their ownership and operations.
- Because exemptions and licensing requirements can vary depending on the business model, prospective DME providers should determine which Florida requirements apply before beginning operations or submitting an application.
Definitions and Criteria
Florida law requires certain persons and entities that provide home medical equipment and related services to obtain a HME (Home Medical Equipment) License. This is defined by Florida Statute 400.93 as:
“(1) Any person or entity that holds itself out to the public as providing home medical equipment and services or accepts physician orders for home medical equipment and services is subject to licensure under this part.”
The statute also applies to persons or entities that hold themselves out as providing home medical equipment that typically requires home medical services, while providing exemptions for certain organizations, practitioners, pharmacies, manufacturers, and other entities.
What is defined as durable medical equipment depends on a general set of criteria. According to Medicare.gov, DME is defined as meeting the following:
- Durable (can withstand repeated use)
- Used for a medical reason
- Typically only useful to someone who is sick or injured
- Used in your home
- Expected to last at least 3 years
This definition covers a wide range of devices, including but not limited to items such as: crutches, wheelchairs, walkers, canes, commode chairs and hospital beds. Whether a particular item qualifies as DME or home medical equipment can depend on the applicable Medicare coverage rules and Florida licensing requirements.
Do You Need a DME License in Florida?
Whether a business needs a Florida Home Medical Equipment (HME) license depends on the equipment being provided, who it is being sold or rented to, and whether the equipment is provided with or typically requires home medical equipment services such as delivery, setup, maintenance, or patient instruction. Florida law generally requires licensure for persons or entities that hold themselves out as providing home medical equipment and services, accept physician orders for home medical equipment and services, or provide home medical equipment that typically requires home medical services.
The licensing requirement is not limited to businesses that bill Medicare or Medicaid. A cash-pay or retail business model does not, by itself, create an exemption from Florida HME licensing requirements.
Florida law does provide exemptions for certain entities and circumstances. These include, among others, certain licensed healthcare facilities, pharmacies, manufacturers and wholesale distributors that do not sell directly to consumers, and licensed healthcare practitioners who use home medical equipment in their practice but do not sell or rent the equipment to their patients.
Businesses selling medical equipment online, shipping products to Florida consumers, using a drop-shipping model, selling used equipment, or operating a retail medical-supply business should evaluate the specific equipment, services, customers, and structure of the business before assuming that HME licensure is or is not required.
Licensing and Locations
In order to begin the licensing process for a DME business in Florida, a business or individual must complete and submit the Home Medical Equipment Provider Application, AHCA Form 3110-1005, which contains the majority of the information required by Florida’s Agency for Health Care Administration (AHCA). This application is very in-depth and it is vital that the information is entered as accurately and completely as possible. AHCA also allows initial applications and certain changes during a licensure period to be submitted through its Online Licensing System, while license renewals must be submitted electronically.
Florida law also requires a separate HME license for each provider operating from a separate premises, even when multiple locations are operated under the same management.
Depending on the structure and setup of the DME business, there are other forms and information required during the application or renewal process. AHCA provides an application checklist giving you an idea of what is required; current AHCA materials also identify forms such as the Health Care Licensing Application Addendum and Proof of Financial Ability to Operate as potentially applicable to HME providers.
However, it can still be difficult for businesses to navigate this process, especially when they are starting out. Because of this, it is strongly recommended to contact an experienced Florida healthcare licensing attorney. An attorney can help identify the licensing, ownership, financial, and supporting-document requirements that apply to the particular business and assist with the application process.
What Are the Requirements for a Florida DME License?
Florida Home Medical Equipment providers must satisfy several licensing requirements beyond submitting the application itself. The specific requirements can depend on the business structure, location, equipment offered, and services provided.
Equipment and services: Applicants must identify the categories of equipment and services they intend to provide, including whether equipment or services will be provided directly or through contracted providers.
Liability insurance: Home Medical Equipment providers must maintain professional and commercial liability insurance. Florida law requires coverage of at least $250,000 per claim, including for contracted providers when applicable.
Physical location and zoning: HME providers are subject to physical-location and zoning requirements established under Florida law and AHCA rules.
Financial ability to operate: AHCA evaluates an applicant’s financial ability to operate as part of the licensing framework.
Background screening: Certain owners, personnel, and other individuals associated with the provider may be subject to Florida healthcare background-screening requirements.
Emergency planning: Licensed HME providers must prepare a Comprehensive Emergency Management Plan (CEMP) and submit the plan as required for the counties listed on the provider’s license.
Out-of-state providers: A provider physically located outside Florida must submit documentation of accreditation, or an application for accreditation, from an accrediting organization recognized by AHCA.
The requirements can differ depending on the equipment supplied and how the business operates, so prospective DME providers should evaluate their proposed business model before submitting the licensing application.
Durable Medical Equipment Licensing Forms
There are several forms that may be required as part of the DME business licensing process in Florida, depending on the applicant and the structure of the business. These forms are available on the Agency for Health Care Administration’s website through its Health Quality Assurance Application for Licensure Forms page. It can be confusing to find these forms on their website so for your convenience, we’ve simplified this by listing several of the forms AHCA identifies for Home Medical Equipment Providers below with download links.
Health Care Licensing Application Home Medical Equipment Provider
This form is officially called the AHCA Form 3110-1005, which is the main form submitted during the application process. License renewal applications must be submitted electronically through AHCA’s Online Licensing System. Initial applications and changes during a licensure period may also be submitted online.
AHCA Form 3110-1005 Download
Application Checklist Home Medical Equipment Provider
This is simply a checklist for those self-applying for a DME license in Florida. Please keep in mind that this checklist is a general guideline and there may be additional requirements for certain individuals and businesses.
Home Medical Equipment Provider Application Checklist Download
Health Care Licensing Application Addendum
This addendum provides additional information concerning controlling interests and certain personnel associated with the applicant or licensee.
AHCA Form 3110-1024 Download
Proof of Financial Ability to Operate
AHCA Form 3100-0009 addresses financial information used to document an applicant’s financial ability to operate. AHCA includes this form among the forms identified for Home Medical Equipment Providers.
AHCA Form 3100-0009 Download
Attestation of Compliance with Background Screening Requirements
This form is used to document compliance with applicable level 2 background screening requirements. The attestation is AHCA Form 3100-0008 and is retained by the provider in accordance with AHCA’s background-screening requirements.
AHCA Form 3100-0008 Download
Home Medical Equipment Provider Request to Amend License for Change of Name And/Or Address
This form is used when there is a change of address or name of the license owner. Additional supporting documentation may be required depending on the type of change.
AHCA Form 3110-1020 Download
