CMS Pub. 100-02, ch. 15, § 110.1

Durable medical equipment is equipment which:

• Can withstand repeated use;

• Is primarily and customarily used to serve a medical purpose;

• Generally is not useful to a person in the absence of an illness or injury; and

• Is appropriate for use in the home.

All requirements of the definition must be met before an item can be considered to be durable medical

equipment.

The following describes the underlying policies for determining whether an item meets the definition of

DME and may be covered.

A. Durability

An item is considered durable if it can withstand repeated use, i.e., the type of item that could normally be

rented. Medical supplies of an expendable nature, such as incontinent pads, lambs wool pads, catheters, ace

bandages, elastic stockings, surgical facemasks, irrigating kits, sheets, and bags are not considered “durable”

within the meaning of the definition. 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.

B. Medical Equipment

Medical equipment is equipment primarily and customarily used for medical purposes and is not generally

useful in the absence of illness or injury. In most instances, no development will be needed to determine

whether a specific item of equipment is medical in nature. However, some cases will require development

to determine whether the item constitutes medical equipment. This development would include the advice

of local medical organizations (hospitals, medical schools, medical societies) and specialists in the field of

physical medicine and rehabilitation. If the equipment is new on the market, it may be necessary, prior to

seeking professional advice, to obtain information from the supplier or manufacturer explaining the design,

purpose, effectiveness and method of using the equipment in the home as well as the results of any tests or

clinical studies that have been conducted.

1. Equipment Presumptively Medical

Items such as 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 presumptively

constitute medical equipment. (Although hemodialysis equipment is covered as a prosthetic device (§120),

it also meets the definition of DME, and reimbursement for the rental or purchase of such equipment for use

in the beneficiary’s home will be made only under the provisions for payment applicable to DME. See the

Medicare Benefit Policy Manual, Chapter 11, “End Stage Renal Disease,” §30.1, for coverage of home use

of hemodialysis.) NOTE: There is a wide variety in types of respirators and suction machines. The DME

MACs medical staff should determine whether the apparatus specified in the claim is appropriate for home

use.

2. Equipment Presumptively Nonmedical

Equipment which is primarily and customarily used for a nonmedical purpose may not be considered

“medical” equipment for which payment can be made under the medical insurance program. This is true

even though the item has some remote medically related use. For example, in the case of a cardiac patient,

an air conditioner might possibly be used to lower room temperature to reduce fluid loss in the patient and to

restore an environment conducive to maintenance of the proper fluid balance. Nevertheless, because the

primary and customary use of an air conditioner is a nonmedical one, the air conditioner cannot be deemed

to be medical equipment for which payment can be made.

Other devices and equipment used for environmental control or to enhance the environmental setting in

which the beneficiary is placed are not considered covered DME. These include, for example, room heaters,

humidifiers, dehumidifiers, and electric air cleaners. Equipment which basically serves comfort or

convenience functions or is primarily for the convenience of a person caring for the patient, such as

elevators, stairway elevators, and posture chairs, do not constitute medical equipment. Similarly, physical

fitness equipment (such as an exercycle), first-aid or precautionary-type equipment (such as preset portable

oxygen units), self-help devices (such as safety grab bars), and training equipment (such as Braille training

texts) are considered nonmedical in nature.

3. Special Exception Items

Specified items of equipment may be covered under certain conditions even though they do not meet the

definition of DME because they are not primarily and customarily used to serve a medical purpose and/or

are generally useful in the absence of illness or injury. These items would be covered when it is clearly

established that they serve a therapeutic purpose in an individual case and would include:

a. Gel pads and pressure and water mattresses (which generally serve a preventive purpose)

when prescribed for a patient who had bed sores or there is medical evidence indicating that

they are highly susceptible to such ulceration; and

b. Heat lamps for a medical rather than a soothing or cosmetic purpose, e.g., where the need for

heat therapy has been established.

In establishing medical necessity for the above items, the evidence must show that the item is included in the

physician’s course of treatment and a physician is supervising its use.

NOTE: The above items represent special exceptions and no extension of coverage to other items should be

inferred.

C. Necessary and Reasonable

Although an item may be classified as DME, it may not be covered in every instance. Coverage in a

particular case is 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. These considerations will

bar payment for equipment which cannot reasonably be expected to perform a therapeutic function in an

individual case or will permit only partial therapeutic function in an individual case or will permit only

partial payment when the type of equipment furnished substantially exceeds that required for the treatment

of the illness or injury involved.

See the Medicare Claims Processing Manual, Chapter 1, “General Billing Requirements;” §60, regarding the

rules for providing advance beneficiary notices (ABNs) that advise beneficiaries, before items or services

actually are furnished, when Medicare is likely to deny payment for them. ABNs allow beneficiaries to

make an informed consumer decision about receiving items or services for which they may have to pay out-of-pocket and to be more active participants in their own health care treatment decisions.

1. Necessity for the Equipment

Equipment is necessary when it can be expected to make a meaningful contribution to the treatment of the

patient’s illness or injury or to the improvement of his or her malformed body member. In most cases the

physician’s prescription for the equipment and other medical information available to the DME MAC will

be sufficient to establish that the equipment serves this purpose.

2. Reasonableness of the Equipment

Even though an item of DME may serve a useful medical purpose, the DME MAC or A/B MAC (A) must

also consider to what extent, if any, it would be reasonable for the Medicare program to pay for the item

prescribed. The following considerations should enter into the determination of reasonableness:

1. Would the expense of the item to the program be clearly disproportionate to the therapeutic

benefits which could ordinarily be derived from use of the equipment?

2. Is the item substantially more costly than a medically appropriate and realistically feasible

alternative pattern of care?

3. Does the item serve essentially the same purpose as equipment already available to the

beneficiary?

3. Payment Consistent With What is Necessary and Reasonable

Where a claim is filed for equipment containing features of an aesthetic nature or features of a medical

nature which are not required by the patient’s condition or where there exists a reasonably feasible and

medically appropriate alternative pattern of care which is less costly than the equipment furnished, the

amount payable is based on the rate for the equipment or alternative treatment which meets the patient’s

medical needs.

The acceptance of an assignment binds the supplier-assignee to accept the payment for the medically

required equipment or service as the full charge and the supplier-assignee cannot charge the beneficiary the

differential attributable to the equipment actually furnished.

4. Establishing the Period of Medical Necessity

Generally, the period of time an item of durable medical equipment will be considered to be medically

necessary is based on the physician’s estimate of the time that his or her patient will need the equipment.

See the Medicare Program Integrity Manual, Chapters 5 and 6, for medical review guidelines.

D. Definition of a Beneficiary’s Home

For purposes of rental and purchase of DME a beneficiary’s home may be his/her own dwelling, an

apartment, a relative’s home, a home for the aged, or some other type of institution (such as an assisted

living facility, or an intermediate care facility for individuals with intellectual disabilities (ICF/IID)).

However, an institution may not be considered a beneficiary’s home if it:

• Meets at least the basic requirement (see §1861(e)(1) of the Social Security Act (the Act)) in the

definition of a hospital, i.e., it is primarily engaged in providing by or under the supervision of

physicians, to inpatients, diagnostic and therapeutic services for medical diagnosis, treatment, and

care of injured, disabled, and sick persons, or rehabilitation services for the rehabilitation of injured,

disabled, or sick persons; or

• Meets at least the basic requirement (see §1819(a)(1) of the Act) in the definition of a skilled nursing

facility, i.e., it is primarily engaged in providing to inpatients skilled nursing care and related

services for patients who require medical or nursing care, or rehabilitation services for the

rehabilitation of injured, disabled, or sick persons.

Thus, if an individual is a patient in an institution or distinct part of an institution which provides the

services described in the bullets above, the individual is not entitled to have separate Part B payment made

for rental or purchase of DME. This is because such an institution may not be considered the individual’s

home (see §§1861(s)(6) and 1861(n) of the Act, the implementing regulations at 42 CFR 410.38(b), and

§2160B in the State Operations Manual (SOM, Pub. 100-07), Chapter 2).

As indicated in §2164 of the SOM, Chapter 2, all hospitals and SNFs that are Medicare-certified are

automatically considered to meet the basic requirement described in the applicable bullet above by reason of

the Medicare certification itself. Moreover, even an institution (or portion of an institution) that is not

certified for Medicare is precluded from being considered a patient’s home in this context if it meets either

of these basic requirements. See §2166 of the SOM, Chapter 2, for the administrative criteria used in

determining whether the basic requirement in the “SNF” definition is met by a nursing home that is not

Medicare-certified (including the non-Medicare portion of an institution that also contains a Medicare-certified distinct part SNF).

If the patient is at home for part of a month and, for part of the same month is in an institution that cannot

qualify as his or her home, or is outside the U.S., monthly payments may be made for the entire month.

Similarly, if DME is returned to the provider before the end of a payment month because the beneficiary

died in that month or because the equipment became unnecessary in that month, payment may be made for

the entire month.