Licensing to Supply Medical Oxygen

Medical oxygen is a prescription drug in federal terms and a home medical equipment product in most state laws, so it collects more licensing rules than anything else a DME supplier ships. A supplier that adds oxygen to a catalog of braces and supplies can go from needing no license in a state to needing two. This walk-through covers the federal rule and the state rules we have verified.

What does Medicare require of oxygen suppliers?

Supplier standard 27 says a DMEPOS supplier "Must obtain oxygen from a State-licensed oxygen supplier (applicable only to those suppliers in States that require oxygen licensure)" (42 CFR 424.57(c)(27)). Standard 1 adds the general rule: where a state requires licensure to furnish an item, the supplier "Must be licensed to provide the item or service," though it "May contract with a licensed individual or other entity to provide the licensed services unless expressly prohibited by State law" (424.57(c)(1)(ii)). The CMS-855S then asks each location to submit "all required licenses for the products and services being provided" in every state it serves (Section 2D).

Which states have an oxygen-specific license?

Florida. Florida's drug law requires "A medical oxygen retail establishment permit ... for an entity that is located in the state and that sells or delivers medical oxygen directly to patients in this state," on a prescription or practitioner's order. A Florida-licensed pharmacy does not need one, and a permit holder "may not possess, purchase, sell, or trade a medical gas other than medical oxygen" unless otherwise authorized (Fla. Stat. 499.83(2)(c)). This is in addition to the AHCA home medical equipment license, though AHCA accepts a valid oxygen retail establishment permit in place of its own periodic licensure inspections (Fla. Stat. 400.933(2)(b)). The permit is written for entities "located in the state"; out-of-state oxygen suppliers should confirm their status. See Florida's HME license.

Wisconsin. Wisconsin has no general DME license but licenses home medical oxygen providers: a "person that provides medical oxygen directly to a consumer or patient in this state for that consumer's or patient's own use." No one may operate as one, use the title or hold itself out as one without the license. Hospitals are exempt, "excluding any home medical oxygen provider that is owned or operated by a hospital" (Wis. Stat. 450.076(1)-(2)). The definition turns on the patient being in Wisconsin, not on where the provider sits.

Where is oxygen written into a pharmacy board permit?

• Virginia. Delivering "medicinal oxygen" on a prescriber's order is part of the definition of a medical equipment supplier (Va. Code 54.1-3401), so an oxygen supplier needs the in-state permit or, from outside Virginia, the nonresident registration (54.1-3435.3:1). Delivery of oxygen under the permit "is limited to delivery to the ultimate user upon lawful order by a prescriber" (54.1-3435.2(C)). See Virginia's permit.
• North Carolina. A device or medical equipment permit holder that dispenses medical oxygen must ensure "Sufficient backup of oxygen in that patient's home and supplies for equipment serviced to maintain continuation of therapy for 24 hours," and keep "An oxygen analyzer in the permitted facility, if concentrators are dispensed" (21 NCAC 46 .1608(a)(3)). The Board's device and medical equipment committee includes a representative of medical oxygen suppliers (21 NCAC 46 .1207).
• Mississippi. The Medical Equipment Supplier Permit covers home medical equipment, legend devices "and/or medical gas," and "Medical gas" means "those gases and liquid oxygen intended for human consumption" (Miss. Code 73-21-108). The Board's Article XXXVIII adds oxygen-specific duties: DOT rules for cylinders and liquid oxygen, FDA rules for transfilling, purity documentation, "lot numbers and expiration dates" on each cylinder, "a tracking system for all medical oxygen and gas delivered," and segregated clean and dirty areas in the facility and vehicles. See Mississippi's permit.
• Louisiana. No one may sell, rent or provide "durable medical equipment, legend devices, and/or medical gas" to Louisiana consumers without a Board of Pharmacy DME permit (La. Admin. Code tit. 46, LIII-2403(A)).
• North Dakota. The Board of Pharmacy licenses medical gas retailers alongside DME retailers, and the fee for a "Medical gas retailer, durable medical equipment retailer, or both" is $200 (N.D. Cent. Code 43-15.3-12).
• Oklahoma. Its DME definition includes "oxygen care and oxygen delivery systems," and the Board issues a combined license for a DME supplier and medical gas distributor (Okla. Admin. Code 535:20-10-2, 535:20-10-3).

How do HME licensing states treat oxygen?

As core home medical equipment. Florida's definition starts with "Oxygen and related respiratory equipment" (Fla. Stat. 400.925(6)(a)). Illinois lists "oxygen and oxygen delivery systems" first (225 ILCS 51/10(6)). Tennessee includes "Oxygen care equipment and oxygen delivery systems" (Tenn. Comp. R. & Regs. 0720-30-.01(21)). Pennsylvania's device definition includes "oxygen equipment" (28 Pa. Code 25.1). California's out-of-state application asks whether a facility "will be selling/renting prescription devices, respiratory equipment, or medical oxygen" and, if so, whether a pharmacist-in-charge or licensed exemptee will be in charge (CDPH 8679O).

Alabama is the sharpest example. Its statute exempts carrier-only mail order companies, but the Board's rule says a company that supplies "respiratory care and oxygen equipment" to Alabama consumers that way "shall not be considered to be a mail order company" (Ala. Admin. Code 473-X-1-.01(8)). Oxygen and respiratory suppliers therefore need the Alabama license, and with it a licensed Alabama location if they are based elsewhere. See Alabama's HME license.

Do Medicaid programs add oxygen conditions?

Coverage conditions rather than licenses, but they shape operations. Pennsylvania's Medical Assistance program pays for oxygen only with "a comprehensive cardiopulmonary evaluation that resulted in an established diagnosis," a prescription stating flow rate and delivery requirements, prior authorization for the first 45 days unless the physician certifies readiness, and physician recertification "at least every 6 months" (55 Pa. Code 1123.55).

What should an oxygen supplier do before shipping to a new state?

1. Check whether the state has an oxygen or medical gas license separate from its DME license (Florida, Wisconsin, North Dakota, Oklahoma).
2. Check whether oxygen triggers a pharmacy board permit you would not otherwise need (Virginia, North Carolina, Mississippi, Louisiana).
3. Check whether oxygen removes an exemption you were relying on (Alabama's mail-order rule).
4. Confirm the source you buy oxygen from is state-licensed where the state requires it (42 CFR 424.57(c)(27)).
5. Build the operational duties into policies before the inspection: backup supply, analyzers, cylinder tracking, cleaning segregation.

How do we help oxygen suppliers?

We map every state you serve for oxygen, medical gas and DME licensing, prepare each application and the oxygen policies inspectors look for, and track renewals. State licenses are $699 per state, $899 for California, Florida, Georgia and Alabama; for wide shipping footprints the Remote Delivery Licensing Package covers 10 states for $4,995 (pricing). Your owner or officer signs and pays each state. See DME license requirements by state.