What makes an item durable medical equipment

Section 1861(s)(6) of the Social Security Act makes durable medical equipment a Part B benefit in three words, and section 1861(n) is where the term is supposed to be defined. Read it and there is no definition in the ordinary sense. The term "includes" iron lungs, oxygen tents, hospital beds and wheelchairs used in the patient's home, whether rented or purchased, and the paragraph then goes on to add specific items by name — blood-testing strips and blood glucose monitors for individuals with diabetes, and eye tracking and gaze interaction accessories for speech generating devices. It is an enumeration that Congress has extended item by item, not a rule an item can be measured against.

The rule is regulatory. 42 CFR 414.202 (opens in a new tab) defines durable medical equipment as equipment, furnished by a supplier or a home health agency, that meets a list of conditions — and the Benefit Policy Manual states, in terms, that all requirements of the definition must be met before an item can be considered to be durable medical equipment. This matters practically: an argument that an item should be DME because it is expensive, or medical-looking, or prescribed, is not an argument the definition can hear.

The first condition asks whether the item can withstand repeated use — the manual's gloss is the type of item that could normally be rented. It is a question about the object, not about how long this patient will need it. Medical supplies of an expendable nature are named: incontinent pads, lambs wool pads, catheters, ace bandages, elastic stockings, surgical facemasks, irrigating kits, sheets and bags. None of them is durable within the meaning of the definition.

The manual then says the thing that is easy to miss, and that changes how the whole category should be read: there are other items that, although durable in nature, may fall into other coverage categories such as supplies, braces, prosthetic devices, artificial arms, legs and eyes. Failing the DME test — or passing it — is a routing answer, not a coverage answer.

Two of the conditions work together: the equipment must be primarily and customarily used to serve a medical purpose, and generally not useful to a person in the absence of an illness or injury. The manual treats a body of familiar items as presumptively medical and needing no development — hospital beds, wheelchairs, hemodialysis equipment, iron lungs, respirators, intermittent positive pressure breathing machines, medical regulators, oxygen tents, crutches, canes, trapeze bars, walkers, inhalators, nebulizers, commodes, suction machines and traction equipment.

The other list is the more useful one, because it is where the arguments happen. Equipment primarily and customarily used for a nonmedical purpose is not medical equipment even where it has some remote medically related use, and the manual works the example: an air conditioner might genuinely help a cardiac patient hold a fluid balance, and it is still not DME, because the primary and customary use of an air conditioner is a nonmedical one. On the same reasoning it excludes room heaters, humidifiers, dehumidifiers and electric air cleaners as environmental control; elevators, stairway elevators and posture chairs as comfort, convenience, or the convenience of the person providing care; physical fitness equipment such as an exercycle; first-aid or precautionary equipment such as preset portable oxygen units; self-help devices such as safety grab bars; and training equipment such as Braille training texts.

A narrow exception exists and the manual fences it off. Certain items may be covered even though they do not meet the definition, where it is clearly established that they serve a therapeutic purpose in the individual case: gel pads and pressure and water mattresses prescribed for a patient who has had bed sores or is shown to be highly susceptible to such ulceration, and heat lamps where a need for heat therapy has been established rather than for a soothing or cosmetic purpose. The evidence has to show the item is part of the physician's course of treatment and that a physician is supervising its use — and the manual adds that these are special exceptions from which no extension of coverage to other items should be inferred.

The last condition is the one that turns on an address. 42 CFR 410.38(a) (opens in a new tab) states the scope: Part B pays for durable medical equipment if the equipment is used in the patient's home or in an institution that is used as a home. The Benefit Policy Manual reads the category generously — a beneficiary's home may be their own dwelling, an apartment, a relative's home, a home for the aged, or another type of institution such as an assisted living facility or an intermediate care facility for individuals with intellectual disabilities.

The exclusions are narrow and specific. 42 CFR 410.38(b) (opens in a new tab) provides that an institution used as a home may not be a hospital, a critical access hospital or a skilled nursing facility, as those are defined in sections 1861(e)(1), 1861(mm)(1) and 1819(a)(1) of the Act. A patient in such an institution is not entitled to separate Part B payment for the rental or purchase of DME, because the place they are in is not their home for this purpose.

Where a beneficiary spends part of a month at home and part in an institution that cannot qualify as a home, the manual permits monthly payment for the entire month; the same holds where equipment is returned mid-month because the beneficiary died or the equipment became unnecessary.

An item can satisfy every condition and still not be paid. The manual is explicit that although an item may be classified as DME, it may not be covered in every instance: coverage remains subject to the requirement that the equipment be necessary and reasonable for treatment of an illness or injury, or to improve the functioning of a malformed body member. Necessity and reasonableness are separate ideas, and the second is the one that surprises people, because it is about the program rather than the patient.

• Necessity — the equipment can be expected to make a meaningful contribution to treating the illness or injury, or to improving a malformed body member. Usually the prescription and the available medical information establish this.
• Reasonableness — three questions the manual puts to the contractor: whether the expense to the program is clearly disproportionate to the therapeutic benefit ordinarily derived from the equipment; whether the item is substantially more costly than a medically appropriate and realistically feasible alternative pattern of care; and whether it serves essentially the same purpose as equipment the beneficiary already has.

Where equipment carries aesthetic features, or medical features the patient's condition does not require, or where a less costly and medically appropriate alternative exists, the amount payable is based on the rate for what meets the medical need rather than for what was supplied. A supplier who accepts assignment is bound by that figure as the full charge. Because a denial on these grounds is a medical-necessity denial rather than a categorical exclusion, it is the advance beneficiary notice that decides whether the beneficiary can be held liable for it.