DME is a benefit for rental of equipment and, therefore, it must be able to withstand repeated use by successive patients (see 42 CFR 414.202 and Chapter 15, Section 110.1 of the Medicare Benefit Policy Manual (CMS Pub. 100-02)). Medicare beneficiaries have the option to receive certain items on a purchase or rental basis. When considering whether an item can withstand repeated use, we may consider factors such as:

• The item may be used by one patient at a time, but when the patient’s course of treatment is complete, the item can then be returned and refurbished for use by another patient. (Note that supplies or accessories for DME may not be re-usable, but they may also be covered under the DME benefit as explained in “Supplies & Accessories.”)
• The item may be available for purchase (see “Questions/Answers”) but it’s also still available for rental and repeated use by successive patients.

Question:

Is DME really a benefit just for equipment rental? Can’t it be purchased?

Answer:

DME can be purchased in limited situations specified in section 1834(a) of the Act and listed below. However, all DME must be equipment that can be rented.

1. Inexpensive items with a purchase price of $150 or less. For example, a cane costs less than $150 and, therefore, can be rented or purchased in accordance with section 1834(a)(2)(A)(i) of the Act and regulations at 42 CFR 414.220(a)(1).
2. Items purchased at least 75% of the time from July 1986- - June 1987 (routinely purchased items) in accordance with section 1834(a)(2)(A)(ii) of the Act and regulations at 42 CFR 414.220(a)(2).
3. Speech generating devices in accordance with section 1834(a)(2)(A)(iv) of the Act.
4. Customized items in accordance with section 1834(a)(4) of the Act and regulations at 42 CFR 414.224, such as a wheelchair which normally can be rented but must be uniquely constructed or substantially modified for a specific beneficiary and is so different from another item used for the same purpose that the 2 items can’t be grouped together for pricing purposes.
5. Complex rehabilitative power-driven wheelchairs in accordance with section 1834(a)(7)(A)(iii) of the Act and regulations at 42 CFR 414.229(h). Suppliers must offer beneficiaries the option to purchase the complex rehabilitative power wheelchair at the time the item is initially furnished. If the beneficiary does not elect the purchase option, then payment for the wheelchair is made on a capped rental basis, where payment is made on a rental basis for no more than 13 months of continuous use, followed by transfer of title to the equipment to the beneficiary. For more information about capped rental items, see Payment Policies for DMEPOS Items & Services.
6. Transcutaneous electrical nerve stimulators (TENS) in accordance with section 1834(a)(10)(C) of the Act and regulations at 42 CFR 414.232(b). TENS must initially be rented for up to 2 months to determine if the device is effective, but can then be purchased or rented following the trial rental period.

For items classified as DME after January 1, 2012, equipment must have an expected life of at least 3 years to be classified as DME (see 42 CFR 414.202 and Chapter 15, Section 110.1 of the Medicare Benefit Policy Manual (CMS Pub. 100-02)). When considering whether equipment meets this requirement, we may consider factors such as:

• Marketing materials, instructions for use, and other documentation that mentions the expected life of the equipment are not in conflict and support the manufacturer claim that the equipment has an expected life of at least 3 years.
• If CMS requests evidence of durability testing, the manufacturer can provide standardized test results from an independent testing laboratory demonstrating that the equipment has an expected lifetime of at least 3 years.

Note: There are additional considerations regarding durability if the item or service is a multi-component system – view “Considerations for Multi-Component Devices.”

Question:

Can you provide more details about testing that would demonstrate equipment is durable?

Answer:

We may request the provision of durability testing results to aid in assessing whether an item or service can be categorized as DME if there are questions about the lifetime of the item. We would expect the manufacturer to provide test results that are:

• Standardized
• Performed by an independent testing laboratory
• Performed to demonstrate that the equipment can last and operate for at least 3 years
• May involve a life cycle assessment, accelerated life testing (e.g., for electrical equipment), or equivalent testing and verifications. The alternative tests should encompass a range of parameters, including but not limited to:
  • Demonstrating durability through repeated use, such as being rented by multiple users, supported by either usage data or simulated usage testing indicating retention of full functionality after three years of regular use.
  • Incorporating various strength, hardness, and physical tests, including but not limited to wear and tear resistance and material degradation/deformation.
  • Conducting stimulation for stressors, component variability, or failure modes.
  • Recommended to include validation factors (e.g., face validity, content validity, construct validity, interval validity, and/or external validity) and reliability factors (e.g., test-retest reliability measures, alternate forms, reliability measures, and/or internal consistency reliability measures).
  • Optionally, conducting environmental exposure simulation.

DME must primarily and customarily serve a medical purpose (see 42 CFR 414.202 and Chapter 15, Section 110.1 of the Medicare Benefit Policy Manual (CMS Pub. 100-02)). When considering whether equipment meets this requirement, we may consider factors such as:

• The equipment makes a meaningful contribution to the treatment of the patient’s illness or injury (see section 1862(a)(1)(A) of the Act).
  • If the equipment is meant to prevent, but not treat, an illness or injury, it isn’t DME. Medicare has separate benefit categories for preventive services.
  • If the equipment is meant only to monitor the illness or injury to report results to the clinician’s office, it isn’t DME. The clinician is performing the medically necessary service to diagnose or treat the patient’s illness or injury based on the monitored information. See Medicare’s Physician Fee Schedule for more information.

Equipment must not generally be useful to the patient in the absence of an illness or injury (see 42 CFR 414.202 and Chapter 15, Section 110.1 of the Medicare Benefit Policy Manual (CMS Pub. 100-02)). For example, smart phones or tablets are useful for many non-medical purposes. When considering whether equipment meets this requirement, we may consider factors such as:

• If the equipment is a personal comfort item, it isn’t DME. Section 1862(a)(6) of the Social Security Act excludes Medicare coverage of items and services which constitute personal comfort items. Personal comfort items, such as massage devices, are further defined in Chapter 16, Section 80 of the Medicare Benefit Policy Manual (CMS Pub. 100-02), which says, “Items that do not contribute meaningfully to the treatment of an illness or injury or the functioning of a malformed body member are not covered.”
• Equipment used for environmental control or to enhance the environmental setting in which the beneficiary is placed are not considered DME. These include room heaters, humidifiers, dehumidifiers, and electric air cleaners.

DME must be appropriate for use in the home (see 42 CFR 414.202 and Chapter 15, Section 110.1 of the Medicare Benefit Policy Manual (CMS Pub. 100-02)). When considering whether equipment meets this requirement, we may consider factors such as:

• Can the beneficiary or caregiver for the beneficiary be instructed on how to safely use the equipment in the home without assistance?
• If there are any coverage exclusions for use of equipment in the home, it can’t be DME. For example, as stated in Chapter 1, Part 1, Section 30.1.1 of the Medicare National Coverage Determinations Manual (CMS Pub. 100-03), home use of biofeedback therapy for the treatment of urinary incontinence isn’t covered by Medicare.

Question:

Does the requirement that an item of DME be appropriate for use in the home prevent the individual from using it outside the home?

Answer:

No. We determine whether equipment serves a medical purpose inside the home when determining if the equipment is DME for Medicare purposes. If equipment is determined to be DME for use by an individual with Medicare in their home, the individual may also use the equipment outside their home.