To operate a durable medical equipment business in Florida, you need a Home Medical Equipment license from the Agency for Health Care Administration (AHCA) before you take a single order. Florida’s statute uses “home medical equipment” rather than “durable medical equipment,” but it covers the same ground: anything the FDA classifies as a medical device, anything reimbursed under Medicare Part B’s DME benefit, and anything covered by Florida Medicaid’s DME program.1Florida Senate. Florida Code 400.925 – Definitions The license runs two years, the application fee is capped at $300 per biennium, and you must carry at least $250,000 in liability insurance per claim.2Florida Senate. Florida Code 400.931 – Application for License; Fee If you plan to bill Medicare, a separate federal track sits on top of the state license.
What Florida Calls It and What Products Are Covered
The statute lists oxygen and respiratory equipment, motorized scooters, personal transfer systems, specialty beds for medical use, and manual, motorized, or customized wheelchairs and related seating and positioning accessories.1Florida Senate. Florida Code 400.925 – Definitions The definition then sweeps in anything else that qualifies as a medical device under federal law or that gets reimbursed by Medicare Part B or Florida Medicaid. If you’re unsure whether a product triggers licensing, check whether it appears on Medicare’s DMEPOS fee schedule or is FDA-registered.
“Home medical equipment services” is defined broadly too: selection, delivery, setup, maintenance, and patient instruction. Providing any of those to consumers in Florida requires a license, even if the equipment itself is manufactured or warehoused out of state.1Florida Senate. Florida Code 400.925 – Definitions
Who Must Apply, and Who Is Exempt
Any person or entity that holds itself out to the public as providing home medical equipment, or that accepts physician orders for it, must be licensed.3Florida Senate. Florida Code 400.93 – Licensure Required; Exemptions; Unlawful Acts; Penalties Storefront, warehouse, online platform — the format doesn’t matter. Each business location needs its own license.
Out-of-state companies are not exempt. If you serve consumers in Florida, you need the license, and you also have to submit documentation of accreditation from an AHCA-recognized organization, or at minimum an accreditation application. If accreditation isn’t finalized within 120 days of AHCA receiving the license application, the application is withdrawn.2Florida Senate. Florida Code 400.931 – Application for License; Fee
Several categories of provider are exempt, but the exemption disappears if you set up a separate company or division to sell or rent equipment to consumers in their homes:3Florida Senate. Florida Code 400.93 – Licensure Required; Exemptions; Unlawful Acts; Penalties
- Facilities run by the Florida Department of Health or the federal government.
- Nursing homes, assisted living facilities serving their own residents, home health agencies, hospices, hospitals, and ambulatory surgical centers.
- Manufacturers and wholesale distributors that don’t sell directly to consumers.
- Licensed health care practitioners who use equipment in treating patients but don’t sell or rent it.
- Pharmacies licensed under Chapter 465.
The pharmacy exemption trips people up. A licensed Florida pharmacy that sells CPAP supplies or nebulizers does not need a separate home medical equipment license. A standalone CPAP supply company does.
What Goes in the Application
Home medical equipment licensing runs under the Health Care Licensing Procedures Act (Part II of Chapter 408) combined with the specific rules in Chapter 400, Part VII. The application is submitted under oath with the required fee. You’ll identify the applicant, the person responsible for day-to-day operations, the financial officer, and each controlling interest, with Social Security numbers for individuals and federal EINs for entities.4Florida Senate. Florida Code 408.806 – License Application Process
You’ll also need to submit:
- A breakdown of the equipment and service categories you plan to provide, directly or through contractors. Equipment categories include respiratory, ambulation aids, mobility aids, sickroom setup, and disposables. Service categories cover intake, equipment selection, delivery, setup, patient training, maintenance, and retrieval.2Florida Senate. Florida Code 400.931 – Application for License; Fee
- The names of any companies you contract with to provide equipment or services, and any providers you supply on a contract basis.
- Documentation showing your legal right to occupy the business premises, such as a deed or lease.5Florida Senate. Florida Code 408.810 – Minimum Licensure Requirements
- Proof of financial ability to operate, including anticipated revenues, expenditures, cash-flow financing, and access to contingency funds.5Florida Senate. Florida Code 408.810 – Minimum Licensure Requirements
- Proof of professional and commercial liability insurance. The statutory floor is $250,000 per claim, and any contractors you use must carry at least the same amount.2Florida Senate. Florida Code 400.931 – Application for License; Fee
The application fee is set by AHCA rule but capped by statute at $300 per two-year period.2Florida Senate. Florida Code 400.931 – Application for License; Fee State, county, and municipal government applicants pay nothing. You cannot operate until AHCA grants final approval.
Background Screening
Florida requires Level 2 background screening — fingerprinting and a check of state and federal criminal history databases — for the licensee (if an individual), the administrator, the financial officer, and any controlling interest where AHCA has reason to believe there may be a disqualifying conviction.6Justia Law. Florida Code 408.809 – Background Screening; Prohibited Offenses Disqualifying offenses are listed in Section 435.04 and generally cover fraud, abuse, neglect, and exploitation. Someone with a disqualifying conviction can apply for an exemption, but nothing is automatic.
A screening completed in the previous five years for any AHCA, Department of Health, or related licensure requirement satisfies the check if the person submits an affidavit of continued compliance under penalty of perjury.6Justia Law. Florida Code 408.809 – Background Screening; Prohibited Offenses When new personnel come on in a role that requires screening, notify AHCA and submit the screening. The person can start work after clearing the state check while the FBI results are pending, but must stop immediately if the federal report shows a disqualifying offense.
Renewal and Ongoing Duties
A home medical equipment license expires two years after its effective date unless suspended or revoked earlier.3Florida Senate. Florida Code 400.93 – Licensure Required; Exemptions; Unlawful Acts; Penalties Renewal applications must reach AHCA at least 60 days before expiration but no more than 120 days before.4Florida Senate. Florida Code 408.806 – License Application Process
Missing the 60-day window triggers a late fee of $50 per day, capped at either 50 percent of the licensure fee or $500, whichever is less.4Florida Senate. Florida Code 408.806 – License Application Process Because the licensure fee itself tops out at $300, the practical maximum late fee is $150. The real risk isn’t the fee, though. If the license lapses before AHCA processes the renewal, you cannot legally operate in the meantime.
You must keep your liability insurance in force and report any material change to AHCA within 21 calendar days, including changes to insurance, bonds, or the information in your original application.5Florida Senate. Florida Code 408.810 – Minimum Licensure Requirements If any screened person’s background check is more than five years old at renewal, a fresh Level 2 screening is required.6Justia Law. Florida Code 408.809 – Background Screening; Prohibited Offenses
Inspections and Operating Standards
AHCA can adopt rules setting minimum standards for staff qualifications and training, financial ability to operate, administration, patient records, compliance with each patient’s plan of treatment, contractual arrangements with other providers, and the physical location. Inspections happen during initial licensing, on routine compliance checks, and in response to complaints, and they are often unannounced. Inspectors review patient service agreements, maintenance records, staff training documentation, and equipment condition. All equipment must meet manufacturer specifications and be in working order before delivery to a patient. Providers must also maintain a comprehensive emergency management plan covering patient equipment and supply lists for situations in which patients need to be transported from their homes.7Florida Senate. Florida Code 400.935 – Rules Establishing Standards
If an inspection turns up deficiencies, you’ll usually get a window to correct them. Failing to correct, or having a deficiency serious enough that it can’t wait, moves the matter into the penalty provisions.
The Federal Layer If You Bill Medicare
State licensure and Medicare enrollment are separate tracks. If you want to bill Medicare, you need both. DMEPOS suppliers must be accredited by a CMS-approved organization before they can enroll in or bill Medicare, as required by Section 1834(a)(20) of the Social Security Act.8Centers for Medicare & Medicaid Services. DMEPOS Accreditation Organizations Medicare enrollment itself runs through Form CMS-855S and carries its own set of requirements on top of the state’s:9Centers for Medicare & Medicaid Services. Medicare Enrollment Application – DMEPOS Suppliers
- Liability insurance of at least $300,000 covering your place of business, customers, and employees. If you manufacture items, coverage must include product liability.
- A $50,000 surety bond for each practice location with a unique NPI, under 42 CFR 424.57(d). CMS contractors can increase the bond by $50,000 for each adverse legal action in the past 10 years.
- A physical facility of at least 200 square feet with space for records storage, a visible sign with posted hours, open to the public at least 30 hours per week, and staffed during those hours.
- A primary business phone listed under the business name in a local directory or a toll-free number available through directory assistance. A cell phone, answering machine, or answering service alone will not satisfy the requirement during posted hours.
Don’t confuse the two regimes. Florida requires liability insurance at $250,000 per claim. Medicare requires liability insurance at $300,000 and a separate $50,000 surety bond. The bond is a federal requirement only.
You’ll also need a Type 2 organizational NPI from the National Plan and Provider Enumeration System, tied to a healthcare taxonomy code matching your DMEPOS category. The NPI is free, but you cannot bill Medicare or most private insurers without one.10NPPES (CMS). NPI Application Help Page And if you bill any federal health care program, screen employees and contractors against the Office of Inspector General’s List of Excluded Individuals/Entities. Hiring an excluded person can expose your business to civil monetary penalties.11Office of Inspector General. Exclusions
Penalties for Operating Without a License
Advertising or offering home medical equipment services without a valid license is both a criminal offense and a deceptive trade practice under the Florida Deceptive and Unfair Trade Practices Act. A first violation is a second-degree misdemeanor. A second or later violation is a first-degree misdemeanor.3Florida Senate. Florida Code 400.93 – Licensure Required; Exemptions; Unlawful Acts; Penalties The state can also seek an injunction to shut down unlicensed operations.
Under the Health Care Licensing Procedures Act, if you keep operating after AHCA notifies you that you’re unlicensed, the fine is $1,000 per day of noncompliance. Where a controlling interest holds licenses for multiple providers and one location operates without proper licensure, AHCA can revoke all of that person’s licenses statewide.12Florida Senate. Florida Code 408.812 – Unlicensed Activity; Penalties Fraudulent billing to Medicare or Medicaid adds federal exposure on top. And a patient harmed by substandard or improperly maintained equipment is a near-certain civil suit. The businesses that end up in the worst position are usually the ones that let a license lapse and kept operating, assuming renewal was a formality. Once the license expires, every day of continued operation is a separate violation.