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 (U.S.) 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 U.S. 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 the TOM,
Appendix A).
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 be 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 Sensors3.12.1 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 Devices3.12.4.1 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 Uniformed Services Medical Treatment Facility (USMTF).
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.