Iowa Code r. 441-78.10 - Durable medical equipment (DME), prosthetic devices and medical supplies
(1)
General
payment requirements. Payment will be made for items of DME,
prosthetic devices and medical supplies, subject to the following general
requirements and the requirements of subrule 78.10(2), 78.10(3), or 78.10(4),
as applicable:
a. DME, prosthetic devices,
and medical supplies must be required by the member because of the member's
medical condition.
b. The item
shall be necessary and reasonable either for the treatment of an illness or
injury, or to improve the functioning of a malformed body part. Determination
will be made by the Iowa Medicaid enterprise medical services unit.
(1) An item is necessary when it can be
expected to make a meaningful contribution to the treatment of a specific
illness or injury or to the improvement in function of a malformed body
part.
(2) Although an item may be
necessary, it must also be a reasonable expenditure for the Medicaid program.
The following considerations enter into the determination of reasonableness:
Whether the expense of the item to the program would be clearly
disproportionate to the therapeutic benefits which could ordinarily be derived
from use of the item; whether the item would be substantially more costly than
a medically appropriate and realistically feasible alternative pattern of care;
and whether the item serves essentially the same purpose as an item already
available to the beneficiary.
c. A physician's (doctor of medicine,
osteopathy, or podiatry), physician assistant's, or advanced registered nurse
practitioner's prescription is required to establish medical necessity. The
prescription shall state the member's name, diagnosis, prognosis, item(s) to be
dispensed, quantity, and length of time the item is to be required and shall
include the signature of the prescriber and the date of signature.
For items requiring prior authorization, a request shall include a physician's, physician assistant's, or advanced registered nurse practitioner's written order or prescription and sufficient medical documentation to permit an independent conclusion that the requirements for the equipment or device are met and the item is medically necessary and reasonable. A request for prior authorization is made using Form 470-5595, Outpatient Prior Authorization Request. See rule 441-78.28 (249A) for prior authorization requirements.
d. Nonmedical items will not be covered.
These include but are not limited to:
(1)
Physical fitness equipment, e.g., an exercycle, weights.
(2) First-aid or precautionary-type
equipment, e.g., preset portable oxygen units.
(3) Self-help devices, e.g., safety grab
bars, raised toilet seats.
(4)
Training equipment, e.g., speech teaching machines, braille training
texts.
(5) Equipment used for
environmental control or to enhance the environmental setting, e.g., room
heaters, air conditioners, humidifiers, dehumidifiers, and electric air
cleaners.
(6) Equipment which
basically serves comfort or convenience functions or is primarily for the
convenience of a person caring for the member, e.g., elevators, stairway
elevators and posture chairs.
e. The amount payable is based on the least
expensive item which meets the member's medical needs. Payment will not be
approved for items that serve duplicate functions. EXCEPTION: A second
ventilator for which prior authorization has been granted. See
78.10(5)"k" for prior authorization requirements.
f. Consideration will be given to rental or
purchase based on the price of the item and the length of time it would be
required. The decision on rental or purchase shall be made by the Iowa Medicaid
enterprise and be based on the most reasonable method to provide the equipment.
(1) The provider shall monitor rental
payments up to 100 percent of the purchase price. At the point that total rent
paid equals 100 percent of the purchase allowance, the member will be
considered to own the item and no further rental payments will be made to the
provider.
(2) Payment may be made
for the purchase of an item even though rental payments may have been made for
prior months. The rental of the equipment may be necessary for a period of time
to establish that it will meet the identified need before the purchase of the
equipment. When a decision is made to purchase after renting an item, all of
the rental payments will be applied to the purchase allowance.
(3) EXCEPTION: Ventilators and oxygen systems
shall be maintained on a rental basis for the duration of use.
(4) A deposit shall not be charged by a
provider to a Medicaid member or any other person on behalf of a Medicaid
member for rental of medical equipment.
g. Payment may be made for necessary repair,
maintenance, and supplies for member-owned equipment. No payment may be made
for repairs, maintenance, or supplies when the member is renting the
item.
h. Replacement of
member-owned equipment is covered in cases of loss or irreparable damage or
when required because of a change in the member's condition.
i. No allowance will be made for delivery,
freight, postage, or other provider operating expenses for DME, prosthetic
devices or medical supplies.
j.
Reimbursement over the established fee schedule amount is allowed when prior
authorization has been obtained. See 78.10(5)"n" for prior
authorization requirements.
(2)
Durable medical
equipment. DME is equipment that can withstand repeated use, is
primarily and customarily used to serve a medical purpose, is generally not
useful to a person in the absence of an illness or injury, and is appropriate
for use in the home.
a. Durable medical
equipment provided in a hospital, nursing facility, or intermediate care
facility for persons with an intellectual disability is not separately payable.
EXCEPTIONS:
(1)
Oxygen services in a nursing facility or an intermediate care facility for
persons with an intellectual disability when all of the following requirements
and conditions have been met:
1. A Certificate
of Medical Necessity for Oxygen, Form CMS-484, or a reasonable facsimile is
completed by a physician, physician assistant, or advanced registered nurse
practitioner and qualifies the member in accordance with Medicare
criteria.
2. Additional
documentation shows that the member requires oxygen for 12 hours or more per
day for at least 30 days.
3. Oxygen
logs must be maintained by the provider. The time between any reading shall not
exceed more than 45 days. The documentation maintained in the provider record
must contain the following:
* The initial, periodic and ending reading on the time meter clock on each oxygen system, and
* The dates of each initial, periodic and ending reading, and
* Evidence of ongoing need for oxygen services.
4. The maximum
Medicaid payment shall be based on the least costly method of oxygen
delivery.
5. Oxygen prescribed
"PRN" or "as necessary" is not payable.
6. Medicaid payment shall be made for the
rental of equipment only. All accessories and disposable supplies related to
the oxygen delivery system and costs for servicing and repair of equipment are
included in the Medicaid payment and shall not be separately payable.
7. Payment is not allowed for oxygen services
that are not documented according to the department of inspections and appeals
requirements at 481-subrule 58.21(8).
(2) Speech generating devices for which prior
authorization has been obtained. See 78.10(5)"f" for prior
authorization requirements.
(3)
Wheelchairs for members in an intermediate care facility for persons with an
intellectual disability.
b. The types of durable medical equipment
covered through the Medicaid program include, but are not limited to:
Automated medication dispenser.
Bathtub/shower chair, bench. See 78.10(5)"g" and "j" for prior authorization requirements.
Commode, shower commode chair. See 78.10(5)"j" for prior authorization requirements.
Decubitus equipment.
Dialysis equipment.
Diaphragm (contraceptive device).
Enclosed bed. See 78.10(5)"a" for prior authorization requirements.
Enuresis alarm system (bed-wetting alarm device) for members five years of age or older.
Heat/cold application device.
Hospital bed and accessories.
Inhalation equipment. See 78.10(5)"c" for prior authorization requirements.
Insulin infusion pump. See 78.10(5)"b" and 78.10(5)"e" for prior authorization requirements.
Lymphedema pump.
Mobility device and accessories. See 78.10(5)"i" for prior authorization requirements.
Neuromuscular stimulator.
Oximeter.
Oxygen, subject to the limitations in 78.10(2)"a" and 78.10(2)"c."
Patient lift. See 78.10(5)"h" for prior authorization requirements.
Phototherapy bilirubin light.
Protective helmet.
Seat lift chair.
Speech generating device. See 78.10(5)"f" for prior authorization requirements.
Traction equipment.
Ventilator.
c. Coverage of home oxygen equipment and
oxygen will be considered reasonable and necessary for members in accordance
with Medicare criteria and as shown by supporting medical documentation. The
physician, physician assistant, or advanced registered nurse practitioner shall
document that other forms of treatment are contraindicated or have been tried
and have not been successful and that oxygen therapy is required. EXCEPTION:
Home oxygen equipment and oxygen are covered for children through three years
of age when prescribed by a physician, physician assistant or advanced
registered nurse practitioner. A pulse oximeter reading must be obtained yearly
and documented in the provider and physician record.
(1) To identify the medical necessity for
oxygen therapy, a Certificate of Medical Necessity for Oxygen, Form CMS-484, or
a reasonable facsimile completed by a physician, physician assistant, or
advanced registered nurse practitioner, shall qualify the member in accordance
with Medicare criteria.
(2) If the
member's condition or need for oxygen services changes, the attending
physician, physician assistant, or advanced registered nurse practitioner must
adjust the documentation accordingly.
(3) A second oxygen system is not covered by
Medicaid when used as a backup for oxygen concentrators or as a standby in case
of emergency. Members may be provided with a portable oxygen system to
complement a stationary oxygen system, or to be used by itself, with
documentation from the physician, physician assistant, or advanced registered
nurse practitioner of the specific activities for which portable oxygen is
medically necessary.
(4) Payment
for oxygen systems shall be made only on a rental basis for the duration of
use.
(5) All accessories,
disposable supplies, servicing, and repairing of oxygen systems are included in
the monthly Medicaid payment for oxygen systems.
(6) Oxygen prescribed "PRN" or "as necessary"
is not allowed.
d.
Wheelchairs, wheelchair accessories, and wheelchair modifications are covered
when they are medically necessary for mobility within the home, nursing
facility, or intermediate care facility. Wheelchairs are defined as:
(1) Standard manual wheelchairs. Coverage of
a standard manual wheelchair includes the following:
1. Complete set of tires/wheels and casters,
any type;
2. Hand rims with or
without projections;
3.
Weight-specific components required by the patient-weight capacity of the
wheelchair;
4. Elevating legrest,
lower extension tube and upper hanger bracket;
5. Armrest (detachable, non-adjustable or
adjustable) with or without arm pad;
6. Footrest (swingaway, detachable),
including lower extension tube(s) and upper hanger bracket;
7. Standard size footplates;
8. Wheelchair bearings;
9. Caster fork, replacement only;
and
10. All labor charges involved
in the assembly of the wheelchair (including, but not limited to: front caster
assembly, rear wheel assembly, ratchet assembly, wheel lock assembly, footrest
assembly).
(2) Standard
manual wheelchair accessories that are separately billable and require prior
authorization include the following:
1.
Headrest extensions;
2. One-arm
drive attachments;
3. Positioning
accessories;
4. Specialized skin
protection seat and back cushions; and
5. Anti-rollback devices.
(3) Standard power wheelchair.
Coverage of a standard power wheelchair requires prior authorization and
includes the following:
1. Lap belt or safety
belt;
2. Battery charger, single
mode;
3. Complete set of
tires/wheels and casters, any type;
4. Legrests (fixed, swingaway, or detachable
non-elevation legrests with or without calf pad);
5. Footrests/foot platform (fixed, swingaway,
detachable footrests or a foot platform without angle adjustment, single
adjustable footplate);
6. Armrests
(fixed, swingaway, detachable non-adjustable height armrests with arm pad
provided);
7. Any weight-specific
components (braces, bars, upholstery, brackets, motors, gears, etc.) as
required by patient-weight capacity of the wheelchair;
8. Any seat width and depth. For power
wheelchairs with a sling/solid seat/back, the following may be billed
separately:
* For standard duty, seat width and/or depth greater than 20 inches;
* For heavy duty, seat width and/or depth greater than 22 inches;
* For very heavy duty, seat width and/or depth greater than 24 inches;
* EXCEPTION: For extra heavy duty, there is no separate billing;
9. Any back width.
For power wheelchairs with a sling/solid seat/back, the following may be billed
separately:
* For standard duty, seat width and/or depth greater than 20 inches;
* For heavy duty, seat width and/or depth greater than 22 inches;
* For very heavy duty, seat width and/or depth greater than 24 inches;
* EXCEPTION: For extra heavy duty, there is no separate billing;
10. Non-expandable
controller or standard proportional joystick (integrated or remote);
and
11. All labor charges involved
in the assembly of the wheelchair (including, but not limited to: front caster
assembly, rear wheel assembly, ratchet assembly, wheel lock assembly, footrest
assembly).
(4) Standard
power wheelchair accessories that are billed separately and require a prior
authorization include the following:
1.
Shoulder harness/straps or chest straps/vest;
2. Elevating legrest;
3. Angle adjustable footplates;
4. Adjustable height armrests; and
5. Expandable controller or nonstandard
joystick (i.e., non-proportional or mini, compact or short throw proportional,
or other alternative control device).
(5) Customized items are payable with a prior
authorization, in accordance with
42 CFR §
414.224.
(3)
Prosthetic devices.
Prosthetic devices mean replacement, corrective, or supportive devices
prescribed by a physician (doctor of medicine, osteopathy or podiatry),
physician assistant, or advanced registered nurse practitioner within the scope
of practice as defined by state law to artificially replace a missing portion
of the body, prevent or correct a physical deformity or malfunction, or support
a weak or deformed portion of the body. This does not require a determination
that there is no possibility that the member's condition may improve sometime
in the future.
a. Prosthetic devices are not
covered when dispensed to a member prior to the time the member undergoes a
procedure which will make necessary the use of the device.
b. The types of prosthetic devices covered
through the Medicaid program include, but are not limited to:
(1) Artificial eyes.
(2) Artificial limbs.
(3) Enteral delivery supplies and products.
See 78.10(5)"l" for prior authorization
requirements.
(4) Hearing aids. See
rule 441-78.14 (249A).
(5) Orthotic devices. See
78.10(3)"c" for limitations on coverage of cranial orthotic
devices.
(6) Ostomy
appliances.
(7) Parenteral delivery
supplies and products. Daily parenteral nutrition therapy is considered
necessary and reasonable for a member with severe pathology of the alimentary
tract that does not allow absorption of sufficient nutrients to maintain weight
and strength commensurate with the member's general condition.
(8) Prosthetic shoes, orthopedic shoes. See
rule 441-78.15 (249A).
(9) Tracheotomy tubes.
(10) Vibrotactile aids. Vibrotactile aids are
payable only once in a four-year period unless the original aid is broken
beyond repair or lost. (Cross reference 78.28(5))
c. Cranial orthotic device. Payment shall be
approved for cranial orthotic devices when the device is medically necessary
for the postsurgical treatment of synostotic plagiocephaly. Payment shall also
be approved when there is documentation supporting moderate to severe
nonsynostotic positional plagiocephaly and either:
(1) The member is 12 weeks of age but younger
than 36 weeks of age and has failed to respond to a two-month trial of
repositioning therapy; or
(2) The
member is 36 weeks of age but younger than 108 weeks of age and there is
documentation of either of the following conditions:
1. Cephalic index at least two standard
deviations above the mean for the member's gender and age; or
2. Asymmetry of 12 millimeters or more in the
cranial vault, skull base, or orbitotragial depth.
(4)
Medical
supplies. Medical supplies are nondurable items consumed in the
process of giving medical care, for example, nebulizers, gauze, bandages,
sterile pads, adhesive tape, and sterile absorbent cotton. Medical supplies are
payable for a specific medicinal purpose. This does not include food or drugs.
However, active pharmaceutical ingredients and excipients that are identified
as preferred on the preferred drug list published by the department pursuant to
Iowa Code section 249A.20A are covered. Medical
supplies shall not be dispensed at any one time in quantities exceeding a
31-day supply for active pharmaceutical ingredients and excipients or a
three-month supply for all other items. After the initial dispensing of medical
supplies, the provider must document a refill request from the Medicaid member
or the member's caregiver for each refill.
a.
The types of medical supplies and supplies necessary for the effective use of a
payable item covered through the Medicaid program include, but are not limited
to:
Active pharmaceutical ingredients and excipients identified as preferred on the preferred drug list published pursuant to Iowa Code section 249A.20A.
Catheter (indwelling Foley).
Colostomy and ileostomy appliances.
Colostomy and ileostomy care dressings, liquid adhesive, and adhesive tape.
Diabetic supplies (including but not limited to blood glucose test strips, lancing devices, lancets, needles, syringes, and diabetic urine test supplies). See 78.10(5)"e" for prior authorization requirements.
Dialysis supplies.
Disposable catheterization trays or sets (sterile).
Disposable irrigation trays or sets (sterile).
Disposable saline enemas (e.g., sodium phosphate type).
Dressings.
Elastic antiembolism support stocking.
Enema.
Hearing aid batteries.
Incontinence products (for members three years of age and older).
Oral nutritional products. See 78.10(5)"m" for prior authorization requirements.
Ostomy appliances and supplies.
Respirator supplies.
Shoes, diabetic.
Surgical supplies.
Urinary collection supplies.
b. Only the following types of medical
supplies will be approved for payment for members receiving care in a nursing
facility or an intermediate care facility for persons with an intellectual
disability when prescribed by the physician, physician assistant, or advanced
registered nurse practitioner:
Catheter (indwelling Foley).
Diabetic supplies (including but not limited to lancing devices, lancets, needles and syringes, blood glucose test strips, and diabetic urine test supplies).
Disposable catheterization trays or sets (sterile).
Disposable irrigation trays or sets (sterile).
Disposable saline enemas (e.g., sodium phosphate type).
Ostomy appliances and supplies.
Shoes, diabetic.
(5)
Prior authorization
requirements. Prior authorization pursuant to rule
441-79.8 (249A) is required for
the following medical equipment and supplies (Cross reference 78.28(1)):
a. Enclosed beds. Payment for an enclosed bed
shall be approved when prescribed for a member who meets all of the following
conditions:
(1) The member has a
diagnosis-related cognitive or communication impairment that results in risk to
safety.
(2) The member's mobility
puts the member at risk for injury.
b. External insulin infusion pumps. Payment
will be approved according to Medicare coverage criteria.
c. Vest airway clearance systems. Payment
will be approved for a vest airway clearance system when prescribed by a
pulmonologist for a member with a diagnosis of a lung disorder if all of the
following conditions are met:
(1) Pulmonary
function tests for the 12 months before the initiation of the vest demonstrate
an overall significant decrease in lung function.
(2) The member resides in an independent
living situation or has a medical condition that precludes the caregiver from
administering traditional chest physiotherapy.
(3) Treatment by flutter device failed or is
contraindicated.
(4) Treatment by
intrapulmonary percussive ventilation failed or is contraindicated.
(5) All other less costly alternatives have
been tried.
d. Rescinded
IAB 12/30/20, effective 3/1/21.
e.
DME rebate agreements. If the department has a current agreement for a rebate
with at least one manufacturer of a particular category of diabetic equipment
or supplies (by healthcare common procedure coding system (HCPCS) code), prior
authorization is required for any equipment or supplies in that category
produced by a manufacturer that does not have a current agreement to provide a
rebate to the department (other than supplies for members receiving care in a
nursing facility or an intermediate care facility for persons with an
intellectual disability). Prior approval shall be granted when the member's
medical condition necessitates use of equipment or supplies produced by a
manufacturer that does not have a current rebate agreement with the
department.
f. Speech generating
device. Payment shall be approved according to Medicare coverage criteria. Form
470-2145, Speech Generating Device System Selection, completed by a
speech-language pathologist and a physician's, physician assistant's, or
advanced registered nurse practitioner's prescription for a particular device
shall be submitted with the request for prior authorization. In addition,
documentation from a speech-language pathologist must include information on
the member's educational ability and needs, vocational potential, anticipated
duration of need, prognosis regarding oral communication skills, prognosis with
a particular device, and recommendations. A minimum one-month trial period is
required for all devices. The Iowa Medicaid enterprise consultant with
expertise in speech-language pathology will evaluate each prior authorization
request and make recommendations to the department.
g. Bathtub/shower chair, bench. Payment shall
be approved for specialized bath equipment for members whose medical condition
necessitates additional body support while bathing.
h. Patient lift, nonstandard. Payment shall
be approved for a nonstandard lift, such as a portable, ceiling or electric
lifter, when the member meets the Medicare criteria for a patient lift and a
standard lifter (Hoyer type) will not work.
i. Power wheelchair attendant control.
Payment shall be approved when the member has a power wheelchair and:
(1) Has a sip 'n puff attachment,
or
(2) The medical documentation
demonstrates the member's difficulty operating the wheelchair in tight space,
or
(3) The medical documentation
demonstrates the member becomes fatigued.
j. Shower commode chairs. Prior authorization
shall be granted when documentation from a physician, physician assistant,
advanced registered nurse practitioner, physical therapist or occupational
therapist indicates that the member:
(1) Is
unable to stand for the duration of a shower or is unable to get in or out of a
bathtub, and
(2) Needs upper body
support while sitting, and
(3)
Needs to be tilted back for safety or pressure relief, if a tilt-in-space chair
is requested.
k.
Ventilator, secondary. Payment shall be approved according to the Medicare
coverage criteria.
l. Enteral
products and enteral delivery pumps and supplies. Payment shall be approved
according to Medicare coverage criteria. EXCEPTION: The Medicare criteria for
permanence is not required.
m. Oral
nutritional products. Payment shall be approved when the member is not able to
ingest or absorb sufficient nutrients from regular food due to a metabolic,
digestive, or psychological disorder or pathology, to the extent that
supplementation is necessary to provide 51 percent or more of the daily caloric
intake, or when the use of oral nutritional products is otherwise determined
medically necessary in accordance with evidence-based guidelines for treatment
of the member's condition. Nutritional products consumed orally are not covered
for members in nursing facilities or intermediate care facilities for persons
with an intellectual disability.
n.
Reimbursement over the established Medicaid fee schedule amount. Payment shall
be approved for bariatric equipment, pediatric equipment or other specialized
medical equipment, supply, prosthetic or orthotic which:
(1) Meets the definition of a code in the
current healthcare common procedure coding system (HCPCS), and
(2) Has an established Medicaid fee schedule
amount that is inadequate to cover the provider's cost to obtain the equipment
or supply.
o. Customized
wheelchairs, subject to the requirements of 78.10(2)"d."
This rule is intended to implement Iowa Code sections 249A.3, 249A.4 and 249A.12.
Notes
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