3.0 Coverage Criteria
3.1 Covered items provided to a beneficiary
as DE includes the following:
• Hospital beds.
• Iron lungs.
• Durable Medical Equipment (DME).
• Wheelchairs.
• Cardiorespiratory monitor under
conditions specified in
Section 2.2.
3.2 A covered DE is provided on a
rental or purchase basis.
3.2.1 Coverage
of DE is based upon the price most advantageous to the Government,
taking into consideration the anticipated duration of the medically
necessary need for the equipment and current price information for
the type of item.
3.2.2 The cost
analysis includes a comparison of the total price of the item as
a monthly rental charge, a lease-purchase price, and a lump-sum
purchase price and a provision for the time value of money at the
rate determined by the United States (US) Department of Treasury.
3.3 A prescribed item of DE that
provides the medically appropriate level of performance and quality
for the beneficiary’s medical condition present is supported by
adequate documentation, as defined in
32
CFR 199.2. Luxury, deluxe, immaterial, or non-essential
features, which increase the cost of the item relative to a similar
item without those features, based upon industry standards for a
particular item at the time the equipment is prescribed or replaced
for a beneficiary, are not authorized. Only the “base” or “basic”
model of equipment (or more cost-effective alternative equipment)
is covered, except as authorized in
paragraphs 3.6,
3.8,
or
4.1.
3.4 The item of DE is prescribed
for a use consistent with required US Food and Drug Administration
(FDA) approved labeling for the item. When prescribed use of an
item appears to be extraordinary, a signed statement from the manufacturer
that a specific medical device is FDA approved for such a use is
adequate evidence that the requirement of FDA approval is met.
3.5 The item of DE is not otherwise
excluded by the regulation and policy (i.e., those found in
32 CFR 199.4(g), to include communication
devices other than those allowed in
Chapter 7, Section 23.1, eyeglasses, exercise/relaxation/comfort
devices, comfort or convenience items).
3.6 DME is DE (see
paragraph 2.2)
that is medically appropriate as defined in
32
CFR 199.2 (see
https://manuals.health.mil/pages/DownloadManualFile.ashx?Filename=Definitions.pdf).
DME Customization. Customization
of DME (i.e., equipment designed permanently to preclude the use
of such equipment by another individual) owned by a beneficiary,
and any accessory or item of supply for any such equipment, may
be covered as determined by the Director (or designee) to be essential
for:
• Achieving therapeutic benefit
for the patient;
• Making the equipment serviceable;
or
• Otherwise assuring the proper
functioning of the equipment.
3.7 Hospital beds (e.g., a manual
or electric fixed height, variable height, semi-electric, heavy
duty extra wide, extra heavy duty) are covered when medically necessary.
• Accessories for hospital beds
are also covered when medically necessary.
3.8 Wheelchairs, which otherwise
meet the DE definition in
paragraph 2.2, are covered to provide medically appropriate
basic mobility.
3.8.1 Electric
wheelchairs. An electric wheelchair, or TRICARE approved alternative
to an electric wheelchair (e.g., scooter), may be provided in lieu
of a manual wheelchair to provide basic mobility. Benefits are not
extended for the use of both an electric-powered, cart-type vehicle
and an electric wheelchair during the same period of time.
3.8.2 Lifts. A vehicle lift, which
otherwise meets the requirements of
paragraph 3.3 and all other
applicable provisions of this policy, may be covered when necessary
to transport an otherwise authorized wheelchair (or an approved
alternative). Coverage is limited to the basic model lift and must
be a temporary (non-permanent/transferable) lift that transports
the wheelchair itself (or an approved alternative).
3.8.2.1 Labor charges are allowed to
cover only the installation of the allowable vehicle wheelchair
lift.
3.8.2.2 The TRICARE program does not
cover transportation of beneficiaries, including to and from medical appointments,
except for ambulances when medical care is provided to the individual
in transit. A lift may be authorized solely to transport the wheelchair
so that a traveling beneficiary has “basic” mobility once at his
or her destination.
3.8.2.3 Vehicle conversions are excluded.
That is conversions such as but not limited to, raising the roof, widening
the door, or permanent attachments installed (e.g., items that are
non-transferable to another vehicle). Purchases and conversions
of personal vehicles for a wheelchair bound beneficiary fall outside
the scope of the TRICARE medical benefits and, therefore, are excluded.
3.8.2.4 The TRICARE program’s allowable
charge is based upon the basic (or standard) model lift and authorized
installation fees. Lifts beyond the basic (or standard) model required
for transport of an authorized wheelchair are excluded from TRICARE
coverage and are not considered in determining the TRICARE allowable costs.
Beneficiaries who choose a lift other than the basic (or standard)
model (i.e., luxury/deluxe) are responsible for the costs above
and beyond the allowable amount of the basic lift. In such a case,
the beneficiary is responsible for submitting sufficient information
regarding the otherwise authorized basic model lift and costs of
installation along with the itemized costs of the luxury/deluxe
model and installation costs.
Note: Refer to
paragraph 4.0 for TRICARE
description of “any item of DE beyond the basic/standard model.”
3.8.3 Modifications of wheelchairs.
Medically appropriate modifications (i.e., slight or small changes
or alterations) to the wheelchair (or an approved alternative) to
accommodate a particular physiological or medical need are covered
when necessary to provide basic mobility and to allow proper use
of the wheelchair. When an otherwise covered wheelchair requires
substantial modification, or is uniquely built to meet the special
needs of a beneficiary, for basic mobility and proper use of the
wheelchair, coverage is provided only under a lump-sum purchase
or rental-purchase agreement resulting in the beneficiary owning
the modified wheelchair.
3.9 Repairs. Benefits are allowed
for repair of beneficiary-owned DE when necessary to make the equipment functional
because of reasonable wear and usage and the manufacturer’s warranty
has expired, but only on the condition that the repair cost is less
than the replacement cost. Coverage includes the use of a temporary replacement
item provided during a reasonable period of repair.
3.10 Replacements.
Benefits are allowed for replacement of beneficiary-owned DE with
documentation that the DE is lost or stolen and not otherwise covered
by another insurance (such as a homeowner’s policy). Replacement
of beneficiary-owned DE is also allowed when the item is not functional
due to normal wear, accidental damage, a change in the beneficiary’s
condition, or the device has been declared adulterated by the FDA.
(Exceptions exist for prosthetic devices; see
Section 4.1 for
more information.)
Note: Replacement is subject to review
of documentation supporting why the current DE item is no longer usable/repairable
and that the replacement cost is less than the repair cost.
Note: Replacement equipment is allowed
only upon a new order or prescription by a TRICARE authorized individual
professional provider with an explanation of the medical need.
3.10.1 When a rented item of DE is lost
or stolen, the supplier shall use modifier RA to notify
the TRICARE contractor that the item has been lost or stolen, and
a replacement item is being provided. Payment for the original rented
item of DE that was lost or stolen is the contractual responsibility
of the supplier.
3.10.2 The TRICARE program will not
continue to pay rental fees on equipment that has been lost or stolen. Once
the medically necessary DE has been replaced by the supplier and
provided to the beneficiary, rental fees for the replacement item
shall resume based upon the continuous use provision, if applicable.
3.11 An item
of DE which otherwise meets the DE benefits requirement that is
essential to provide a fail-safe in-home life-support system, or
that replace in-like-kind an item of equipment that is not serviceable
because of normal wear, accidental damage, a change in the beneficiary’s
condition, has been declared adulterated by the FDA, or is being,
or has been recalled by the manufacturer, is not considered duplicate
and, therefore is covered.
Note: For the purpose of this policy,
“duplicate” means an item of equipment that meets the definition
of DE and serves the same purpose as an item of DE previously cost-shared
by the TRICARE program. For example, various models of a stationary
oxygen concentrator with no significant differences are considered
duplicates, whereas stationary and portable concentrators are not
considered duplicates of each other because the latter is intended
to provide a beneficiary with mobility outside the home. Another
example is an electric wheelchair, which otherwise meets the definition
of DE would not be duplicative of a manual wheelchair previously
cost-shared by the TRICARE program in that the electric wheelchair
provides independent mobility not provided by the manual wheelchair.
3.12 Mobile
Medical Applications (MMAs), Digital Therapeutics, and Sensors
3.12.1 MMAs, also known as mHealth apps,
software-as-a-medical device, and digital therapeutics, are applications
that operate using a smartphone, tablet, smart watch, or other mobile
platform; are designed to benefit an individual’s health or wellness;
and either meet the definition of a medical device, are an accessory
to a medical device, or transform a mobile platform into a medical
device.
3.12.2 MMAs must meet all of the following
criteria to be eligible for TRICARE coverage:
• Meet TRICARE’s definition for DME
in
32 CFR 199.2 and
all requirements for coverage under TRICARE’s DME policy as described
in this manual section.
• Be determined by the Defense Health
Agency (DHA) to be proven safe and effective according to the hierarchy of
reliable evidence, as described in
32
CFR 199.2 and
32 CFR 199.4,
and listed as eligible for coverage in
paragraph 3.12.5.
• Be condition-specific (meaning
they must treat a specific health condition rather than support
an individual overall health and wellness), be medical in nature
as defined in
32 CFR 199.2,
and be medically or psychologically necessary.
• Be prescribed by a TRICARE-authorized
provider acting within the scope of their license. Prescriptions
are required annually for subscription-based MMAs.
• Be approved or cleared by the FDA.
• Comply with Health Insurance Portability
and Accountability Act (HIPAA) requirements.
3.12.3 For MMAs that require a monthly
subscription, the contractor shall conduct a medical necessity evaluation
after three months and then every 12 months afterwards. For an annual
subscription, the contractor shall conduct the evaluation annually.
3.12.4 Sensors
And Connected Medical Devices
3.12.4.1 Sensors are technology designed
to take biometric readings from patients and upload that information
to a platform for use with an MMA. Sensors may include medical devices
such as blood pressure monitors, thermometers, electrocardiograms,
and blood glucometers, as well as non-medical equipment such as fitness
trackers. Connected medical devices integrate with an mHealth app
but do not, themselves, monitor the patient.
3.12.4.2 Sensors and connected medical devices
must be consistent with existing regulations and policies for DME
to be covered under the TRICARE Program.
• Platforms that do not meet TRICARE’s
definition of DE or DME, including smartphones, electronic tablets, personal
computers, and smart watches, are excluded from coverage.
3.12.4.3 Covered MMAs that work with a covered
sensor or connected medical device may not be separately reimbursed
unless the MMA provides a medically necessary service independent
from the covered sensor or connected medical device. For example,
an MMA that operates with a covered Continuous Glucose Monitoring System
(CGMS) that only provides a visualization of data from the CGMS
is ineligible for coverage. Separate reimbursement for both the
sensor or connected medical device and the MMA may only be provided
if separate reimbursement is applied to all payers, including patients
who purchase out of pocket; otherwise, separation of charges constitutes
abusive charges in accordance with
32
CFR 199.9.
3.12.4.4 For sensors and connected medical
devices that require an MMA to function (i.e., the sensor/medical device
and MMA function as one unit), then both the equipment and the MMA
must be eligible for coverage to receive reimbursement.
3.12.4.5 If an MMA meets coverage criteria,
but the associated sensor or connected medical device does not meet
TRICARE coverage criteria, no separate reimbursement may be provided
for the sensor or connected medical device. For example, if TRICARE
were to determine that an MMA was proven, but the MMA works as an
application on a smartphone, TRICARE may cover the MMA but not the
smartphone and/or associated data/voice plans.
3.12.5 MMAs are not covered under the
basic benefit unless TRICARE determines that the MMA meets all criteria
detailed under
paragraph 3.12.2. MMAs that are eligible for
coverage will be listed in this paragraph; all other MMAs are excluded
from coverage. Currently, no MMAs meet TRICARE coverage criteria.
5.0 EXCLUSIONS
5.1 DE for a beneficiary who is
a patient in a type of facility that ordinarily provides the same
type of DME item to its patients at no additional charge in the
usual course of providing its services is excluded.
5.2 DE that is available to the
beneficiary from a Military Medical Treatment Facility (MTF).
5.3 An item of DE that has been
lost or stolen (except as provided in
paragraph 3.10), or for an
item under warranty, or when a DE is damaged while using the equipment
in a manner inconsistent with its common use.
5.4 DE with luxury, deluxe, immaterial,
or non-essential features, which increase the cost of the item relative to
a similar item without those features, based upon industry standards
for a particular item at the time the equipment is prescribed or
replaced for a beneficiary. (See
paragraph 4.0 for Policy Consideration.)
5.5 Exercise, relaxation, comfort,
sporting items, or sporting devices. Exercise equipment, to include wheelchairs
and items primarily and customarily designed for use in sports or
recreational activities, spas, whirlpools, hot tubs, swimming pools
health club memberships or other such charges, or items.
5.6 Repairs of deluxe, luxury,
or immaterial features of DE (except as provided in
paragraph 3.9).
5.7 Repairs of DE damaged while
using the equipment in a manner inconsistent with its common use.
5.8 Maintenance agreement.
5.9 Routine periodic servicing,
such as testing, cleaning, regulating, and checking which the manufacturer does
not require be performed by an authorized technician.
5.10 Duplicate
items of otherwise allowable DE to be used solely as a back-up to
currently owned or rented equipment, except as provided in
paragraph 3.11.
5.11 DE must be considered durable
(i.e., withstands repeated use). Therefore, DE does not include expendable
items (e.g., incontinent pads, diapers, ace bandages). Such items
are excluded from DE coverage. Refer to
Section 6.1 for
policy regarding supplies and dressings (consumables).
5.12 Non-medical equipment (e.g.,
humidifier, electric air cleaners, exercycle, safety grab bars,
training equipment). See
32 CFR 199.4.
5.13 Beds that are not medical in
nature and used for comfort or convenience (e.g, power or manual
lounge beds, sleep-number beds, ordinary beds typically sold as
furniture) are excluded. This includes beds designed
to prevent falls and protect individuals from entanglement and entrapment
while in the bed (e.g., Beds by George Haven, Cubby beds) and all
accompanying accessories.
