Durable Medical Equipment (DME), Orthotics & Prosthetics Form

Page 1 of 31 Clinical Policy: Durable Medical Equipment and Orthotics and Prosthetics Guidelines Reference Number: CP.FC.06

    Coding Implications

Date of Last Revision: 9/2025 This policy does not apply to Medicare Revision Log

See Important Reminder at the end of this policy for important regulatory and legal information.

Description
Durable medical equipment (DME) is defined as equipment that can withstand repeated use, is primarily and customarily used to serve a medical purpose, is appropriate for use in the home, and is generally not useful to a person in the absence of an illness or injury. Orthotic devices are rigid and semi-rigid devices used for the purpose of supporting a weak or deformed body part or restricting or eliminating motion in a disease or injured body part. Prosthetic devices are custom- made artificial limbs or other assistive devices that replace a body part or function as a result of traumatic injuries, vascular disease, diabetes, cancer or congenital disorders.

Benefit Limits: Benefit limits for all DME items for all lines of business except Medicare will follow the benefit limits in the current New York State Medicaid Program Durable Medical Equipment, Orthotics, Prosthetics, And Supplies Procedure Codes And Coverage Guidelines.

Pediatric members (age<21) may exceed benefits if there is demonstration of need for new item due to growth.

Documentation that the item is broken and not repairable will allow benefit limit to be exceeded.

Policy/Criteria I. It is the policy of Fidelis Care that durable medical equipment, orthotics, and prosthetics are medically necessary when the general and applicable equipment-specific criteria in A and B are met: A. General criteria: All of the following:

1. Equipment is necessary and reasonable for the treatment of an illness or injury or to improve the functioning of a physical deficit;*
2. Both of the following have been provided to the member/enrollee and/or caregiver, as applicable: a. Education regarding use of the device, with demonstrated understanding; b. A trial of the requested device, with demonstrated ability to use it safely and effectively.
   *Note:
   • 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.
   • Although an item of DME may serve a useful medical purpose, additional considerations should be made to whether the item is reasonable, such as, whether the expense of the item is disproportionate to the therapeutic benefits, whether it is substantially more costly

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than a medically appropriate and realistically feasible alternative plan of care, and/or whether the item will serve essentially the same purpose as equipment already available. • Additional "deluxe" features or items that are rented or purchased for aesthetic reasons or added convenience, do not meet the reasonableness test.
• If a medically necessary, lesser cost item exists and will suit the member/enrollee's medical needs, a higher cost item will be denied.

B. EQUIPMENT-SPECIFIC CRITERIA AMBULATORY ASSIST PRODUCTS ..................................................................................... 2 BURN GARMENTS .............................................................................................................. 3 CARDIAC EQUIPMENT ....................................................................................................... 3 COMPRESSION THERAPY EQUIPMENT .............................................................................. 3 DIABETES CARE EQUIPMENT ............................................................................................ 3 HEAT, COLD & LIGHT THERAPY EQUIPMENT ................................................................. 4 NEWBORN CARE EQUIPMENT ........................................................................................... 4 OTHER EQUIPMENT ........................................................................................................... 4 OTHER EQUIPMENT ........................................................................................................... 6 PROSTHETICS AND ORTHOTICS EQUIPMENT ................................................... 6 PUMPS .............................................................................................................................. 11 RESPIRATORY EQUIPMENT ............................................................................................. 11 STIMULATOR EQUIPMENT............................................................................................... 14 SURGICAL SUPPLIES ........................................................................................................ 16 WHEELCHAIRS ................................................................................................................ 17 WOUND CARE ...................................................................... Error! Bookmark not defined.

AMBULATORY ASSIST PRODUCTS CRITERIA HCPCS Gait trainers

For Medicaid/CHP: use current NYS Medicaid Program Durable Medical Equipment, Orthotics, Prosthetics, And Supplies Procedure

For HBX, EPP: use current MCG (Pediatric Gait Trainer) E8000 E8001 E8002 Standing Frames

For HBX, EPP members: use current NYS Medicaid Program Durable Medical Equipment, Orthotics, Prosthetics, And Supplies Procedure

**Line item justification is required for any additional components submitted under the E1399 code.

E0637
E0638 E0641 E0642 **E1399

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BURN GARMENTS CRITERIA HCPCS Burn garments

All LOB except Medicare: Medically necessary with associated physical and/or occupational therapy when all of the following criteria are met: • The burn is of documented significance to place the member at risk of a post-burn contracture;
• The burn garment and physical and/or occupational therapies are being used with the intent of preventing the need for skin grafting or contractures as a result of hypertrophic scarring;
•

A6501 A6502 A6503 A6504 A6505 A6506 A6507 A6508 A6509 A6510 A6511 A6512 A6513

CARDIAC EQUIPMENT CRITERIA HCPCS External defibrillator with integrated ECG analysis- Medicaid, CHP, EPP, HBX: Not medically necessary, as it is primarily considered a safety
device E0617

COMPRESSION THERAPY EQUIPMENT CRITERIA HCPCS Pneumatic compression devices Medicaid/ CHP : use current NYS Medicaid Program Durable Medical Equipment, Orthotics, Prosthetics, And Supplies Procedure

EPP/ HBX: use current MCG (Intermittent Pneumatic Compression with Extremity Pump)

E0650, E0651, E0652 Non-pneumatic compression devices All LOB except Medicare Not medically necessary, as there is insufficient clinical evidence to support the safety and effectiveness of non-pneumatic compression devices over the use of standard pneumatic compression devices. E0678, E0679 E0680 E0681

DIABETES CARE EQUIPMENT CRITERIA HCPCS Blood glucose monitor with integrated voice synthesizer
Medicaid/CHP: use current NYS Medicaid Program Durable Medical Equipment, Orthotics, Prosthetics, And Supplies Procedure

EPP, HBX, Medically necessary for members with diabetes who are legally blind (best corrected visual acuity of 20/200 or worse in both eyes).

E2100

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HEAT, COLD & LIGHT THERAPY EQUIPMENT CRITERIA HCPCS Ultraviolet panel lights
Medicaid/CHP:

HBX, EPP: Medically necessary for members who have both: • Refractory psoriasis; • MD must justify treatment at home versus alternate sites (e.g.
Outpatient department at hospital). Panel lights should be considered, if several discrete body areas can be treated individually.
Note: Cabinet style should be reserved for extensive involvement
of body surface area.
E0691 E0692 E0693 E0694 Cold pad pump
CHP, EPP, HBX, Medicaid: Not medically necessary for post-operative management, as research does not indicate improved outcomes in pain or edema management with the use of cold compression therapy over the use of other treatments to include conservative treatment, cold therapy alone, compression therapy alone, etc.

E0236

NEWBORN CARE EQUIPMENT CRITERIA HCPCS Breast pumps Medicaid/CHP: use current NYS Medicaid Program Durable Medical Equipment, Orthotics, Prosthetics, And Supplies Procedure

EPP, HBX: Medically necessary for members for the following: • Breast/ chest feeding member if it is a covered benefit in the State, and
•
E0604 OTHER EQUIPMENT CRITERIA HCPCS Positioning seat- Medicaid/CHP: use current NYS Medicaid Program Durable Medical Equipment, Orthotics, Prosthetics, And Supplies Procedure

EPP, HBX: Medically necessary when all of the following are met:

• Documentation of therapist evaluation and ongoing treatment plan; • Commercial device must be unable to meet the positioning needs of the member due to height, weight, or disability; • Other positioning devices in the home must be reviewed to ensure a duplication of devices is not already in place; T5001 E1399

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Enclosed Beds Excludes Medicare and Medicaid. For MCD coverage refer to DME Procedure Codes Manual Medically necessary when meeting all of the following:

A. Standard bed or standard hospital bed must be unable to meet the positioning needs due to disability; B. Less intensive alternatives to improve the member’s/enrollee’s safety have been tried and ruled out (To include documentation of why
medical needs could not be met). Considerations include, but are not limited to :

1. Bed rails;
2. Mattress placed on the floor;
3. Removal of all safety hazards;
4. Bed alarms;
5. Video/audio monitors;
6. Child protection devices such as locks on doors, windows, cabinets, furniture anchors, gates at steps and doors;
7. Physician-directed medication to address seizures, behaviors and sleep;
8. Environmental modification to encourage calming behaviors and sleep;
9. Established routines addressing sensory needs and/or behavior modification to assist with improved naptime or night time behaviors and sleep;
   C. Diagnosis including but not limited to any of the following:
10. Cerebral palsy;
11. Developmental delay;
12. Genetic or neurological disorder that would cause vertigo,
    disorientation, or uncontrolled movement of the body or extremities;
13. Uncontrolled seizure disorder;
14. Severe behavior disorder;
    D. Healthcare provider evaluation (typically from an occupational or physical therapist) includes all of the following:
15. Specific information on functional status;
16. Documentation of home evaluation;

17. Documentation of education provided to caregivers on proper use of a bed enclosure, noting: they are to be used for medical support, improved safety transitioning in and out of the bed, and improved safety while sleeping;
    E. Name of and invoice for the bed or enclosure being requested.

    Note:
    • Enclosed beds should not be used as a discipline measure or as a restraint during times of high agitation or aggression. To limit sensory deprivation, enclosed beds should be used at night for sleeping and only for short rests or naps during the day. • When the above criteria are met, only basic beds will be considered medically necessary. Upgrades for aesthetic purposes or upgrades that do not meet the rules for durable medical equipment (DME) will not be covered as part of an enclosed bed purchase. This includes but is not limited to any of the following: E0316 E1399

    E0328 or E0329 (when combined with E0316 or E1399)

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NEWBORN CARE EQUIPMENT CRITERIA HCPCS • Special lights, sounds, fans, cameras, two way talk monitors, vibration pads, weighted blankets;
• Custom wood types, finishes or engravings, special coverings on the outside of the bed;
• Custom upgrades where lower cost alternatives are readily available.

OTHER EQUIPMENT CRITERIA HCPCS ROMTech® PortableConnect® Device Not medically necessary, as there is insufficient evidence in published peer-reviewed literature to support the use of this technology over currently available alternatives. E1399, A9900

PROSTHETICS AND ORTHOTICS EQUIPMENT CRITERIA HCPCS Traction equipment & fracture frames. Medicaid/CHP: E0947 and E0948 not covered E0849- use current NYS Medicaid Program Durable Medical Equipment, Orthotics, Prosthetics, And Supplies Procedure

EPP, HBX: Home traction therapy is unproven and considered experimental/investigational, not medically necessary. E0849, E0947, E0948 Rollabout chair
Medicaid/CHP: Not covered

HBX, EPP: Medically necessary when used in lieu of a wheelchair for members who would qualify for a wheelchair (except for the ability to self- propel a manual wheelchair). E1031 Flexion/extension devices All LOB except Medicare: refer to Centene policy CP.MP.144 Mechanical stretching devices policy

Hip orthotics
All LOB except Medicare

Medically necessary when ordered by an orthopedic surgeon for treatment of, or postoperatively for any of the following: A. Total hip arthroplasty; L1640, L1680, L1685, L1686, L1690

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PROSTHETICS AND ORTHOTICS EQUIPMENT CRITERIA HCPCS B. Hip labral tear; C. Hip disorders in children when used to stabilize the hip and/or to correct and maintain hip abduction.
Lateral replacements due to growth are considered medically necessary in pediatrics for diagnoses such as hip dysplasia with Charcot-Marie-Tooth disease.

Requests for hip orthotics for hip osteoarthritis in patients who are not surgical candidates will be reviewed on a case by case basis by a medical director and/or therapy advisor.

Legg Perthes orthotics
All LOB except Medicare

Medically necessary when ordered by an orthopedic surgeon for use in the treatment for Legg-Calvé-Perthes disease in children. L1700, L1710, L1720, L1730, L1755

Shoulder, elbow, wrist, hand, finger orthotics
All LOB except Medicare

Medically necessary when ordered immediately post-operative for orthopedic surgeries such as rotator cuff repair, tendon repair, or ORIF.

Replacement with the same or similar item due to normal wear and tear is considered medically necessary when the orthotic is still needed.

L3720, L3730, L3740, L3760, L3900, L3901, L3904, L3960, L3962,
L3999, L4000, L4010, L4020, L4030, L4205 Controlled Ankle Movement (CAM) Walker/ Boot All LOB except Medicare

Medically necessary and covered for: 1.Ankle sprains (grade II & III) 2.Fracture of the distal fibula or lateral malleolus, nondisplaced, without associated tibial fracture or medial malleolus fracture

3. Spiral fracture of distal tibia, nondisplaced
4. Juvenile osteochondritis dessicans involving ankle joint
5. Fracture of the metatarsal shaft, nondisplaced L4360, L4361, L4386, L4387

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PROSTHETICS AND ORTHOTICS EQUIPMENT CRITERIA HCPCS

5. Fracture of the base of fifth metatarsal
6. Following ankle/ foot surgery (ie.ORIF)

7. Can be considered for off loading in diabetic foot ulcer Charcot Restraint Orthotic Walker (CROW) All LOB except Medicare

   Medically necessary and covered for:

8. Neuropathic diabetic foot (plantar) ulcers for mechanical off loading
9. Charcot arthropathy

10. Achilles tendon rupture (partial or complete) for nonsurgical management for select group of patients (ie. nonactive, elderly)

    Code L4631 includes all additions including straps and closures. No additional codes may be billed with code L4631. L4631 Scoliosis Orthosis

    Kyphosis Orthosis

    All LOB except Medicare

    Medically necessary when all of the following are met:

11. Radiological imaging showing Cobb angle 20-50 degree
    2.Skeletal immaturity as determined by Risser grade 0-3. Spinal Orthosis not otherwise specified (L1499) will be reviewed on a case by case basis (demonstration of why standard equipment cannot meet member’s need) Note for L0720:
    In addition to above must have one of the following: thoracic curve with apex at or above T8, or 2) double thoracic curves (high- left and lower-right thoracic curve pattern and right thoracic/left thoracolumbar pattern)

    Medically necessary when one of the following are met:

12. Persistent pain and symptoms despite conservative management: strengthening and stretching exercises, analgesics, and avoidance of precipitants

13. Kyphosis of more than 60°

    The use of HCPCS code L0999 (addition to spinal orthosis, not otherwise specified) or L1499 (spinal orthosis, not otherwise L0720, L1000, L1001, L1005, L1006, L1200, L1300, L1310,

    L1020, L1025 (additions to base codes)

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PROSTHETICS AND ORTHOTICS EQUIPMENT CRITERIA HCPCS

Pectus Carinatum Orthosis specified) must not be used to bill for any features or functions included in the base code nor should it be used when a specific L- code exists. Use of these two codes in these circumstances is considered incorrect coding (unbundling).

HCPCS codes L1499 and L0999 should not be used as base codes for a scoliosis or kyphosis orthosis.

Medically necessary to restore function and alleviate symptoms when all of the following are met:
• Member has been evaluated by a physician (for example a pediatric surgeon) who specializes in the treatment of pectus carinatum and that physician recommends bracing. • Member has skeletally immature (flexible chest wall) as determined by Risser score 0-3. • Member has been educated by the prescribing physician that long term rigorous compliance with this treatment is required for effectiveness Not recommended for pectus excavatum, pectus carinatum with Haller index (pectus severity index) less than or equal to 2, or severe pectus arcuatum

L1320 Prosthetics and additions: Upper Extremity and Myoelectric Medically necessary when the request specific criteria in A. or B. are met:

A. Initial request meets all of the following:

1. Medical record documentation supports all of the following: a. Functional needs cannot be met with activity modification and compensatory techniques; b. Requested prosthesis is anticipated to meet functional needs;
2. Clinical examination findings include all of the following:
   a. Appropriate residual limb length;
   L6000, L6010, L6020, L6026, L6028, L6029, L6030, L6031, L6032, L6033, L6050, L6055, L6100, L6110, L6120, L6130, L6200, L6205, L6250, L6300, L6310, L6320, L6350, L6360, L6370, L6380, L6382, L6384, L6386, L6388, L6400, L6450, L6500,
   L6550, L6570, L6580, L6582, L6584, L6586, L6588, L6590, L6623, L6624, L6625, L6628,

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PROSTHETICS AND ORTHOTICS EQUIPMENT CRITERIA HCPCS b. Limb volume stable;
c. Ability to tolerate weight of prosthetic device; d. Environmental exposures appropriate for requested prosthesis;
e. Ability to access specialized service and care as necessary;
f. Stable condition of extremity to include skin integrity, strength, and ROM sufficient to use requested device;
g. Cognitive function necessary to master prosthetic use;

3. Comprehensive prosthetic rehabilitation plan includes all of the following:
   a. Successful participation in pre- prosthetic training and therapy;
   b. Method of prosthetic control discussed;
   c. Functional task training with occupational or physical therapy;
   d. Concurrent home exercise program;
   e. Follow-up care schedule planned.
   B. Replacement request, all of the following:
4. Replacement is requested due to one of the following:
   a. Current prosthesis no longer functions properly or physiological or surgical changes to residual limb no longer accommodate current prosthesis;
   b. Irreparable wear to prosthesis or prosthetic components;
   c. Significant change in member/enrollee condition resulting in poor fit or function of prosthesis or prosthetic components;
5. Irreparable damage to prosthesis or prosthetic components or repair cost > 60% of replacement cost;
6. Prosthesis has been properly cared for following manufacturer's recommendations;
7. Medical documentation includes all of the following:
   L6638, L6646, L6647, L6648, L6689, L6690, L6692, L6693, L6700, L6704, L6707, L6708, L6709, L6711, L6712, L6713, L6714, L6715, L6721, L6722, L6885, L6895, L6900, L6905, L6910, L6915, L6920, L6930, L6940, L6950, L6960, L6965, L6970, L6975, L7040, L7170, L7185, L7186, L7405, L7406, L7499

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PROSTHETICS AND ORTHOTICS EQUIPMENT CRITERIA HCPCS a. Supports continued use and medical need;
b. Continued motivation to use the device for functional benefit;
c. Functional level continues to be appropriate for prosthesis and components in use;
d. Replacement with same or similar prosthesis and/or components;
e. Updated practitioner's order on file or order not required (for loss or irreparable damage).
Breast Prosthetics For all lob except Medicare.
Medically necessary post- masectomy or for treatment of gender dysphoria. If the request is for a custom prosthetic, accompanying documentation must state the reason why a prefabricated device is not adequate. L8030 L8035 Myoelectric Rehabilitation Systems For all lob except Medicare Not medically necessary, as there is insufficient evidence in published peer- reviewed literature to support the effectiveness of these devices.
E0738E0739

PUMPS CRITERIA HCPCS Vacuum erection device
Medicaid: use current NYS Medicaid Program Durable Medical Equipment, Orthotics, Prosthetics, And Supplies Procedure

EPP, HBX: A vacuum erection device (VED) and tension ring are not medically necessary for the treatment of erectile dysfunction. L7900

RESPIRATORY EQUIPMENT CRITERIA HCPCS Nebulizer, ultrasonic
Medicaid/CHP: use current NYS Medicaid Program Durable Medical Equipment, Orthotics, Prosthetics, And Supplies Procedure

EP, HBX: Medically necessary for members when used for delivery of pentamidine or aerosolized antibiotics. E0575 IPPB & supplies
Medicaid/CHP: use current NYS Medicaid Program Durable Medical Equipment, Orthotics, Prosthetics, And Supplies Procedure

EPP, HBX:
Medically necessary for members with respiratory disease when an incentive spirometer is ineffective.
E0500 E0550

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RESPIRATORY EQUIPMENT CRITERIA HCPCS Oximeter
Medicaid/CHP: use current NYS Medicaid Program Durable Medical Equipment, Orthotics, Prosthetics, And Supplies Procedure

HBX, EPP: Medically necessary when used as a monitoring and alarm device for any of the following: • To monitor individuals on a home ventilator or with a tracheostomy • To determine appropriate home oxygen requirements • To wean an individual from home oxygen • To monitor an unstable respiratory condition Not medically necessary when used for the following: • Oximetry when used as a diagnostic procedure • Monitoring of a stable respiratory condition • Asthma management • Other conditions not listed above E0445

Intrapulmonary percussive ventilation devices (Volara™, Percussionaire- TRUE-IPV®) For all lob except Medicare Current evidence does not support the effectiveness of intrapulmonary percussive ventilation (IPV). E1399 Oxygen supplies Medicaid/CHP: Refer to current NYS DME Oxygen Systems coverage guidelines

EPP, HBX: Home oxygen therapy is covered for 1 or more of the following: • Continuous oxygen therapy needed as indicated by oxygen saturation < 88% or PaO2 < 55 mm Hg at rest (awake) or with exercise • Continuous oxygen therapy needed as indicated by oxygen saturation < 89% or PaO2 56 - 59 mm Hg with Cor pulmonale, peripheral edema suggestive of heart failure, or hematocrit greater than 55% • Cancer (advanced) with breathlessness and subjective improvement with oxygen or improvement of walking distance with oxygen • Central sleep apnea as indicated by confirmed diagnosis of congestive heart failure on optimized medical therapy and CPAP ineffective or poorly tolerated • Cluster headache and patient receiving preventive headache therapy (eg, verapamil) • Congenital heart disease with cyanosis or elevated pulmonary vascular pressure • Pediatric pulmonary disease and oxygen saturation less than 93% • Pulmonary hypertension; adult with oxygen saturation < 90% or PaO2 < 59 mm Hg, or child with oxygen saturation < 92%
Portable oxygen: E1392 S8120 S8121

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RESPIRATORY EQUIPMENT CRITERIA HCPCS • The member/enrollee meets criteria above for home oxygen therapy and is mobile within the home or community (self or with a caretaker able to assist member with mobility device). E1392 is not reimbursable in conjunction with any other oxygen system (codes E1390, E0424, E0431, E0434 or E0439).

Note:

• Portable oxygen systems are covered when the practitioner's order specifies that the portable system is medically necessary.
• Oxygen therapy must be re-ordered once every 365 days or more frequently if the member's need for oxygen changes, as well as all medical documentation to substantiate coverage criteria.
• All home oxygen therapy services are reimbursed on an all-inclusive rate that may be billed once per 30 days.
• As with all rentals the 30-day fee includes all necessary equipment (e.g. oxygen tank holder)
• A “spot check” pulse oximeter for intermittently checking oxygen levels is included in the monthly rental reimbursement for all oxygen systems

• Portable oxygen concentrator, rental (E1392): The 30-day rate includes all oxygen needs: stationary, portable and emergency gaseous supply in place for a power outage, malfunction of the concentrator, or other emergency situations.

  Ventilator

  Second home ventilator Medicaid/CHP: use current NYS Medicaid Program Durable Medical Equipment, Orthotics, Prosthetics, And Supplies Procedure

  EPP, HBX: Medically necessary for members with a long-term/chronic condition or disease affecting the ability to effectively maintain adequate respiratory status. Examples of conditions may include neuromuscular disease, thoracic restrictive disease, or chronic respiratory failure following COPD.

  A second invasive or non-invasive ventilator is considered medically necessary if required for a different purpose from the first ventilator, based on the member’s medical needs. Examples include: • Two different types of ventilators are needed for each day, e.g., negative pressure ventilator with chest shell for one indication and a positive pressure ventilator with nasal mask the rest of the day;
  • Member is confined to a wheelchair and requires a wheel-chair mounted ventilator during the day and another ventilator of the same type for use while in bed. Without both pieces of equipment, member may be prone to medical complications, unable to achieve appropriate medical outcomes, or may not be able to use the equipment effectively.
  Members residing in remote areas with poor emergency access may also be considered for a second ventilator. E0465 E0466 Tubing with integrated Medicaid/CHP/EPP/HBX: A4604

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RESPIRATORY EQUIPMENT CRITERIA HCPCS heating element for use with positive airway pressure device Heated tubing will be covered when the treating provider documents treatment failure of heated humidifier to resolve side effects of PAP therapy. The heated tubing (A4604) is not medically necessary for members on: • PAP therapy for obstructive sleep apnea. • PAP therapy for obstructive sleep apnea who already have heated humidification (E0562 Humidifier, heated, used with positive airway pressure device).

STIMULATOR EQUIPMENT CRITERIA HCPCS Neuromuscular stimulator Medicaid/CHP:

EPP, HBX:

Medically necessary (E0745) when used as one component of a comprehensive rehab program for the treatment of disuse atrophy when the nerve supply to the atrophied muscle is intact and has any of the following indications for disuse atrophy:
• Contractures due to burn scarring; • Previous casting or splinting of a limb; • Major knee surgery with failure to respond to physical therapy; • Recent hip replacement until physical therapy begins.

Neuromuscular electrical stimulation for any other indication (e.g., idiopathic scoliosis [E0744], heart failure) is not medically necessary because it is considered not proven safe and effective or unproven. E0745 Functional neuromuscular stimulator
Medicaid/CHP:

EPP, HBX:

Medically necessary for members with a spinal cord injury (SCI) who meet ALL the following criteria: • The member/enrollee has brisk muscle contraction to stimulation and sensory perception of electrical stimulation sufficient for muscle contraction; • At least six months have passed since recovery from spinal cord injury and restorative surgery; • Member/enrollee is highly motivated, committed, and has the cognitive ability to use FES devices for walking;
• Successful completion of a training program consisting of at least 32 physical therapy sessions with the device over a three-month period; • Member/enrollee demonstrates a willingness to use the device long- term; • None of the following contraindications are present: E0764

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STIMULATOR EQUIPMENT CRITERIA HCPCS  Cardiac pacemaker;  Severe scoliosis or severe osteoporosis;  Skin disease or cancer at area of stimulation;  Irreversible contracture;  Autonomic dysreflexia; • If lower extremity FES is requested, all of the following:  Intact lower motor units (L1 and below, including both muscle and peripheral nerve);  Muscle and joint stability adequate for weight bearing at upper and lower extremities and can demonstrate balance and control to maintain an upright support posture independently;
 Transfers independently and demonstrates independent standing tolerance for at least three minutes;  Demonstrates hand and finger function to manipulate controls;  No hip and knee degenerative disease and no history of long bone fracture secondary to osteoporosis

HCPCS codes that do not support coverage criteria: E0744: Neuromuscular stimulator for scoliosis Peroneal nerve stimulators
Medicaid/CHP:

EPP, HBX :

Peroneal nerve stimulators (e.g., NESS L300, NESS L300 Plus, L300 Go System, WalkAide, Odstock (ODFS) Dropped Foot Stimulator) are medically necessary for incomplete spinal cord injury.

Peroneal nerve stimulators, (e.g., NESS L300, NESS L300 Plus, L300 Go System, WalkAide, Odstock (ODFS) Dropped Foot Stimulator) have not been proven safe and effective for any indication other than incomplete spinal cord injury, including, but not limited to: foot drop in cerebral palsy, multiple sclerosis, traumatic brain injury, or stroke.

Neuromuscular electrical stimulation for any other indication (e.g., idiopathic scoliosis, heart failure) is not proven safe and effective. E0770 Implantable neurostimulator
Medicaid/CHP:

HBX, EPP:

L8681 L8684 L8689

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STIMULATOR EQUIPMENT CRITERIA HCPCS Diaphragmatic pacing is medically necessary for the treatment of chronic ventilatory insufficiency due to bilateral paralysis or severe paresis of the diaphragm in members with partial or complete ventilatory insufficiency that retain sufficient function in the phrenic nerves, lungs and diaphragm to accommodate electrical stimulation.

See CP.MP.12 Vagus Nerve Stimulation for criteria for implantation of stimulator for epilepsy and depression.

SURGICAL SUPPLIES CRITERIA HCPCS Ambulatory infusion pump
Medicaid, CHP, EPP, HBX:

Medically necessary for members when used for one of the following: A. Iron Poisoning: when used in the administration of deferoxamine for the treatment of acute iron poisoning and iron overload; B. Chemotherapy for liver cancer: when used in the treatment of primary hepatocellular carcinoma or colorectal cancer where this disease is unresectable; OR, where the patient refuses surgical excision of the tumor; C. With opioid drugs when used in the treatment of intractable pain caused by cancer. D. To safely administer a drug considered reasonable and necessary by either:

1. Prolonged infusion of at least 8 hours because of proven improved clinical efficacy (i.e., proven or generally accepted to have significant advantages over intermittent bolus administration regimens or infusions lasting less than 8 hours) or

2. Intermittent infusion, each episode of infusion lasting less than 8 hours, and both of the following criteria: a. Does not require the member to return to the physician's office prior to the beginning of each infusion.
   b. Strictly controlled rate of infusion is necessary because systemic toxicity or adverse effects of the drug are unavoidable without infusing it at a controlled rate as indicated in the Physicians Desk Reference, or the U.S. Pharmacopeia Drug Information E0781 Implantable infusion pumps
   Medicaid/CHP:

   HBX, EPP:

   Medically necessary for members when used for one of the following: A. Chemotherapy for liver cancer

3. Primary hepatocellular carcinoma or Duke’s Class D colorectal cancer, in which the metastases are limited to the liver and where either the disease is unresectable, or the patient refuses excision of the tumor; E0782 E0783 E0785 E0786

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SURGICAL SUPPLIES CRITERIA HCPCS B. Anti-spasmodic drugs for severe spasticity

1. When administered intrathecal to treat chronic intractable spasticity in patients unresponsive to less invasive medical therapy including both of the following: a. A 6-week trial of noninvasive methods, such as oral anti- spasmodic drugs, that failed to adequately control the spasticity or produced intolerable side effects;
   b. Prior to pump implantation, member responded favorably to a trial of intrathecal dose of the anti-spasmodic drug; C. Opioid drugs for treatment of chronic intractable pain, see current version criteria of MCG: A-0420 Intrathecal Pump Implantation- D. Other uses of implantable infusion pumps when all of the following are met:
2. The drug is reasonable and necessary for the treatment of an individual member;
3. It is medically necessary that the drug be administered by an implanted infusion pump. The infusion pump has been FDA- approved for the drug being administered and the purpose for which it is being administered. E. None of the following contraindications to implantation of an infusion pump:
4. Known allergy or hypersensitivity to the drug being used (e.g., oral baclofen, morphine, etc.);
5. Active infection;
6. Body size insufficient to support the weight and bulk of the device;
7. Presence of another implanted programmable device;

8. Heparin or insulin is the drug intended for administration

   WHEELCHAIRS CRITERIA HCPCS Robotic Arm, Wheelchair-mounted (JACO) There is insufficient clinical evidence to support safety and improved health outcomes of the JACO Assistive Robotic Arm (Kinova, Inc.) over other technologies. E1399

   Coding Implications Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to- date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services.

   Background DME items have the following characteristics: • The equipment is prescribed by a physician; • The equipment meets the definition of DME;

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• The equipment is necessary and reasonable for the treatment of a member’s illness or injury; • The equipment is manufactured primarily for use in the home environment but is not limited to use in the home.

Member’s Home For purposes of rental and purchase of DME, a member’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.
However, an institution may not be considered a member’s home if the following are met: • Meets at least the basic requirement in the definition of a hospital, i.e., it is primarily engaged in providing by or under the supervision of physicians, to inpatient, 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 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 members who require medical or nursing care, or rehabilitation services for the rehabilitation of injured, disabled, or sick persons.
Members who have been permanently admitted to an inpatient skilled nursing facility or inpatient hospice and who have changed their home address to that of the SNF or hospice will have the SNF or hospice defined as their home.

Products
Products is defined as a listing of the most common items, or group of items, that are or may be perceived as home medical equipment. This listing, while reasonably complete, is not intended to quantify the entire spectrum of products that may be considered DME either now or in the future.

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 incontinence pads, lamb’s wool pads, catheters, ace bandages, elastic stockings, surgical facemasks, 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 and orthotics and prosthetics. Orthotics and Prosthetics items include, but are not limited to, braces, artificial limbs and eyes.

Medical Equipment
Medical equipment is defined as equipment primarily and customarily used for medical purposes and is not generally useful in the absence of illness or injury. In most instances, no documentation will be needed to support whether a specific item of equipment is medical in nature. However, some cases will require documentation to determine whether the item constitutes medical equipment. This documentation would include the advice of local medical organizations and facilities 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,

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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.

Personal computers or mobile technology such as iPads, smart phones, iPods, personal digital assistants, etc., may be considered as medical equipment when used for the purpose of speech generating equipment when other non-medical functions are limited or disabled and that device is used as the primary source of communication for those qualifying for a speech generating device.

Replacements for lost / stolen/ damaged DME items Replacement of all or part of a member-owned DME item may be considered medically necessary when both of the following (A and B) are met:
A. The DME item(s) continues to be medically necessary for the member (this should be certified by a physician /provider written order and/or certificate of medical necessity; and
B. One or more of the following conditions are met:

1. The current DME item(s) has been lost or stolen and not otherwise covered by another insurance (such as a homeowner’s policy).
   a. For lost/stolen DME item(s), provide letter from member or caregiver describing circumstances of the loss/stolen, including the approximate date of loss/stolen and the specific actions to be taken with the replacement to avoid future loss. For items over $250, a police report is required. Lost or stolen item(s) will not be replaced more than twice: or b. For damaged DME item(s), the item is not under manufacturer or supplier warranty , unless a warranty specifically excludes an item (the health plan pays for reasonable and necessary labor and parts not otherwise covered under manufacturer’s or supplier’s warranty)
2. An accessory required for the effective use of a DME item is irreparably worn and the replacement part needed is no longer available and cannot be substituted with another manufacturer's part. Example: An electrical nerve stimulator unit's lead wires are no longer manufactured and cannot be substituted with another brand. Therefore, the nerve stimulator unit itself is effectively nonfunctional and must be replaced.
3. One month rental of equipment may be covered while a member-owned DME item is being repaired or while waiting for a replacement of the current member-owned DME item.

4. Replacement of DME is not covered for the following: a. Replacements and maintenance for items/devices required during a rental period. These are the contractual responsibility of the item/device provider. b. Replacement of items due to malicious damage, neglect or abuse. c. Replacement on the sole basis of new or improved technology when the current DME item is functional and meets the member’s current basic functional medical needs. d. Replacement of items still covered under manufacturer warranty and maintenance services

   Reviews, Revisions, and Approvals

   Revisio n Date Approva l Date Policy created
   06/09 06/09 Updated HCPCS codes for existing criteria to current DME PA list VAD replacement parts, protective helmet, and Q4100 & Q4118 removed d/t removal from DME PA list.
   01/15 02/15

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Reviews, Revisions, and Approvals

Revisio n Date Approva l Date Added traction equipment/fracture frame Removed emergency response system criteria as no longer on the DME PA list Added male vacuum erection device Added ambulatory infusion pump criteria Added specific criteria for gait trainers and positioning chairs Specialist Review (PT & OT) 2015 codes added: L6026 and L7259 to prosthetic section and L3981 added to shoulder orthotic section 03/15

Updated HCPCS codes per 2016 CMS mandate, removed deleted codes. Changed “lymphedema pumps” to “pneumatic compression devices” for lymphedema or arterial insufficiency. Removed oral device criteria and codes which are now covered in MCG Updated template, retitled to CP.MP.107 02/16 02/16 Moved language from Policy/Criteria sections A, B, and C to background and removed definitions of necessary and reasonable. Deleted diagnostic equipment table and moved oximetry to respiratory table, and biofeedback to other equipment table. Clarified that oximetry for diagnostic screening is not a DME use. 07/16 07/16 Removed A6503, E0656, E0657, E0221, E0270, E0840, E0850, E0855, E0856, E0860, E0870, E0880, E0890, E0800, E0930, E0941, E0942, E0945, E0946, L2861, L5969, E0746, E2120, E0457, E0459, E0462, E0744, E0762, L8685, Q4114, Q4130 as they are not on DME or O&P PA list Removed L5782, L6621, L6686, L6687, L6688, L6694, L6695, L6696, L6697, L6698, L6880, L6881, L6682, L7007, L7008, L7009, L7045, L7180, L7181, L7190, L7191, L7366, L7404, L8680, L8682, L8683, L8686, L8687, L8688 because other criteria now exists Added implantable cardiac event recorder as medically necessary in some cases of cryptogenic stroke Added E1801, E1818, L0648, L0650, L0651, L6020, L6026, L6500, Q4111 as they are on PA and no other criteria exists
01/17 02/17 Added background section on use of mobile devices as speech generating devices. 09/17 09/17 Removed the following codes because other criteria now exists: E0670, L2999, L3981, B9002, B9004, B9006. Classified L7900 (vacuum erection device), and L7902 as not medically necessary per Medicare LCD.
Revised language for Ambulatory Infusion Pumps –section C. to state opioid drugs rather than morphine. Added criteria for prolonged and intermittent infusions under Ambulatory Infusion Pumps, section D.
01/18 01/18

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Reviews, Revisions, and Approvals

Revisio n Date Approva l Date Revised section on Orthotic Care Equipment, Hip/Knee/Ankle/Foot Orthotics (L2050, L2060, L2090) noting that when requested, they would be reviewed on a case by case basis. Added E0770, Peroneal Nerve Stimulation as investigational and not medically necessary to section on Stimulator Equipment. 07/18 07/18 Added A6511 to section on Burn garments. Deleted section for enteral pumps and supplies because other criteria exists. Added reference to CP.MP.117, Spinal Cord Stimulation in section on Implantable neurostimulator.
12/18 12/18 Changed section “Parenteral pumps and supplies” to “Parenteral pumps for medication administration”, changed criteria from TPN use only to uninterrupted medication administration, per code description. In implantable infusion pump, replaced chronic non-malignant pain criteria with a reference to CP.MP.173 intrathecal pain pumps. Other minor rewording for clarity with no clinical significance. Updated flexion/extension devices according to current MCG availability: removed E1801 and added E1802 & E1812 04/19 04/19 Added hip labral tears as an indication for a Hip Orthotic; Removed criteria for flexion/extension devices, and associated codes E1802, E1810, and E1812 as they are now in CP.MP.144 Mechanical Stretch Devices 10/20 10/20 Clarified benefit limits; Pediatric members (age<21) may exceed benefits if there is demonstration of need for new item due to growth; Documentation that the item is broken and not repairable will allow benefit limit to be exceeded; deleted CMO signature line;
1/21 1/21 CAM walker/CROW Boot criteria added ; changed header from Centene to Fidelis 03/21

Idiopathic Adolescent Scoliosis Orthosis criteria added; changed “Centene Corporation” to “Fidelis Care” within Important Reminder section 04/21

Added criteria for enclosed beds to “Other Equipment” section of policy. Added references and codes E0316, E1399 and E0328 or E0329 (when combined with E0316 or E1399) for enclosed beds. Replaced “experimental/investigational” with “not proven safe and effective” in the following sections: Pneumatic compression devices, neuromuscular stimulator, and peroneal nerve stimulators. Added Standing Frames criteria with new initial request and replacement request criteria. Added criteria for Wheelchair-mounted Assistive Robotic Arm (JACO) and added references. Changed “review date” in the header to “date of last revision” and “date” in the revision log header to “revision date.”
08/21

Reorganized Standing Frame criteria and required that replacement requests also meet existing criteria for the initial request. For initial request under 18, added "and one of the following: Developmental delay 09/21

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Reviews, Revisions, and Approvals

Revisio n Date Approva l Date in ambulation and ≥ 18 months of age; Documented neurological or neuromuscular impairments and ≥ 1 year of age.” Required that documentation supports meeting height and weight requirements, alert and responsive to stimuli, no contraindications to standing program, and caregiver trained, available, and able to safely assist. Removed requirement for “able to tolerate upright position.” Added informational note. Annual review. References reviewed and updated. Added burn garment HCPCS codes A6502, A6503, A6504, A6505, A6506, A6508, A6509, A6510, A6512 and A6513 to policy.
Under Stimulator equipment, added code E0744 as HCPCS code that do not support coverage criteria. Added peroneal nerve stimulators are medically necessary for incomplete spinal cord injury. Added that peroneal nerve stimulators and neuromuscular electrical stimulation have not been proven safe and effective for any other indications than those listed.

07/22

Added section and criteria for “Replacements for lost/ stolen/ damaged DME items”. 10/22

Updated policy statement in I. and added general criteria I.A.1. and I.A.2. Revised heading for policy table to Equipment Specific Criteria. Updated Gait Trainers to defer to MCG (Pediatric Gait Trainer) and Standing Frames criteria to defer to NYS DME criteria. Updated pneumatic compression device criteria and added non-pneumatic compression device criteria. Removed "male" from male vacuum erection device. Added section and criteria for Oxygen supplies for E1392, S8120, S8121. Minor verbiage and formating updates with no impact on criteria. References reviewed, updated, and reformatted.
02/23

Annual review. Updated description with no impact on criteria. Changed Orthopedic Care Equipment to Prosthetics and Orthotics Equipment. Table of contents updated. Updated "Cabinet style..." note under Ultraviolet panel lights. Under “Other Equipment” added section, criteria, and coding (E1399, A9900) for “ROMTech device”. Added section, criteria and coding for Prosthetics and additions: Upper Extremity and Myoelectric in “Prosthetics and Orthotics Equipment” section. Added section, criteria, and coding (L8701, L8702) for “MyoPro Orthosis” under “Prosthetics and Orthotics Equipment”.
Added section and criteria for "Breast Prosthetics" (L8030, L8035).
Updated Functional neuromuscular stimulator section: Combined criteria applicable to LE units into a separate section and Additional contraindications added. Removed “CHP” from EPP/HBX line of business (lob) criteria section and added to Medicaid lob for coverage 12/23

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Reviews, Revisions, and Approvals

Revisio n Date Approva l Date alignment. References reviewed, updated, and reformatted. Internal specialist review. Added A4604 (Tubing with integrated heating element for use with positive airway pressure device) to section on Respiratory Equipment. References updated. 01/24

Removed contraindications under Functional neuromuscular stimulator
including uncontrolled cardiac arrhythmias, unstable angina, joint replacement in a location targeted by FES and seizure disorder.
References reviewed and updated. Reviewed by external specialist. 07/24

Annual Review. Added to header “ This policy does not apply to Medicare”. Removed Medicare and Medicaid criteria listed in Criteria sections. Medicaid criteria replaced with direction to use of current NYS DME instead. Added “except Medicare” to criteria stating “All LOB”. Replaced codes K1032 and K1033 with E0678 and E0679 under non-pneumatic compression devices. Added additional note to enclosed bed section. Updated verbiage in Newborn Care Equipment, Breast Pumps for inclusivity. Added additional note to enclosed bed section. Updated criteria under hip orthotics. Added section, criteria, and coding (L2006) for “Microprocessor-controlled knee-ankle-foot orthoses (KAFO)” under “Prosthetics and Orthotics Equipment”.
Added criteria and coding for “Kyphosis Orthosis” under Scoliosis section. Added additional note regarding codes (L099) and L1499 to Scoliosis/ Kyphosis section. Removed code L4130 under shoulder, elbow, wrist, hand, finger orthotics. Added section, criteria and coding (L1399) for “Intrapulmonary percussive ventilation devices” under
“Respiratory Equipment”. In Implantable infusion pump: in criteria C. removed reference to “CP.MP.173 Implantable Intrathecal Pain Pumps” and replaced with “MCG A-0420 Intrathecal Pump Implantation” and added criteria E. contraindications to implantation of an infusion pump.
References reviewed and updated. 1/25

Added in Pneumatic compression devices section note “use current MCG (Intermittent Pneumatic Compression with Extremity Pump)” for EPP/HBX line of business. Removed from Pneumatic compression devices section for MCD/CHP statements “Medically necessary as an accessory… and “For lymphedema of the abdomen…” and added “use current NYS Medicaid Program Durable Medical Equipment, Orthotics, Prosthetics, And Supplies Procedure”. Added to non- pneumatic compression devices section “All LOB except Medicare”. Added section, criteria and coding for Pectus Carinatum orthosis (L1320). Added L1006 (scoliosis orthosis). 07/2025

Minor update to description with no impact on criteria. Minor update to "Considered not medically necessary" statements throughout policy for clarity (removed verbiage “considered)”. Under burn garments removed 09/2025

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References

1. New York State Medicaid Program Durable Medical Equipment, Orthotics, Prosthetics, And Supplies Procedure Codes And Coverage Guidelines, current edition: Version 2025 (4/1/2025)
2. National coverage determination: Durable medical equipment (DME) reference list (280.1). Centers for Medicare and Medicaid Services website. https://www.cms.gov/medicare-coverage-database/search.aspx. Published May 16,
3. Accessed June 10, 2025.
4. Local coverage article. Knee orthoses – policy article (A52465). Centers for Medicare & Medicaid Services website. http://www.cms.hhs.gov/mcd/search.asp. Published October 1, 2015 (revised January 1, 2025) Accessed June 10, 2025.
5. DMEPOS quality standards. Centers for Medicare & Medicaid Services website.
   https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network- MLN/MLNProducts/DMEPOSQuality/DMEPOSQualBooklet-905709.html. Published December 2022. Accessed June 10, 2025.

6. Medicare Claims Processing Manual. Chapter 20 – Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS). Centers for Medicare & Medicaid Services website. https://www.cms.gov/regulations-and- Reviews, Revisions, and Approvals

   Revisio n Date Approva l Date criteria “Garment requested by...” Updated blood glucose monitor criteria from < 20/200 to 20/200 or worse in both eyes." Removed
   verbiage of “not covered” in reference to Medicaid/CHP LOB throughout policy. Removed limit and cost criteria from breast pump section. Minor verbiage updates to positioning seat section with no impact to criteria. Minor verbiage updates to enclosed beds section with no impact to criteria. Removed “non covered” from MCD/CHP and changed to “ALL LOB except Medicare” in flexion/extension devices section. Removed HCPCS code L2006 and Microprocessor controlled KAFO criteria. Minor rewording to shoulder, elbow, wrist, hand, finger orthotics with no impact to criteria. Added HCPCS code L0720 and criteria to Scoliosis section. Added HCPCS codes L6028, L6029, L6030, L6031, L6032, L6033, L6700, L7406 to upper extremity and myoelectric prosthetics and additions. Updated previous "MyoPro Orthosis" section to "Myoelectric Rehabilitation Systems" removed HCPCS codes L8701 and L8702 and added E0738 and E0739 with updated "Not medically necessary" statement. Removed HCPCS codes E0455 and oxygen tent criteria. Removed HCPCS codes E1310 and "Whirlpool tub" section. Added to A. General criteria: “Equipment is necessary and reasonable…” along with corresponding note. Added codes E0680 and E0681 to non-pneumatic compression devices.
   References reviewed and updated.

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guidance/guidance/manuals/downloads/clm104c20.pdf#:~:text=)%20Usually%20th is%20is%20the%20least%20costly,a%20more%20expensive%20item%20may%20 be%20medically. Published March 28, 2024. Accessed June 10, 2025.

6. Local coverage article. Surgical dressings (A54563). Centers for Medicare & Medicaid Services website. http://www.cms.hhs.gov/mcd/search.asp. Published October 1, 2015 (revised December 5, 2024). Accessed June 10, 2025.
7. Rea TD, Eisenberg MS. Automated external defibrillators. UpToDate. http://www.utdol.com. Published March 5, 2024. Accessed June 10, 2025.
8. Piccini JP Sr, Allen LA, Kudenchuk PJ, et al. Wearable Cardioverter-Defibrillator Therapy for the Prevention of Sudden Cardiac Death: A Science Advisory From the American Heart Association. Circulation. 2016;133(17):1715-1727. doi:10.1161/CIR.0000000000000394
9. Al-Khatib SM, Stevenson WG, Ackerman MJ, et al. 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society [published correction appears in J Am Coll Cardiol. 2018 Oct 2;72(14):1760. doi: 10.1016/j.jacc.2018.08.2132.]. J Am Coll Cardiol. 2018;72(14):e91-e220. doi:10.1016/j.jacc.2017.10.054
10. National coverage determination. Pneumatic compression devices (280.6). Centers for Medicare & Medicaid Services website. http://www.cms.hhs.gov/mcd/search.asp. Published January 14, 2002. Accessed June 10, 2025.
11. Evidence analysis research brief: Dayspring (Koya Medical Inc.) for treatment of lymphedema. Hayes. www.hayesinc.com. Published March 27, 2023. Accessed June 10, 2025.
12. National coverage determination. Home blood glucose monitors (40.2). Centers for Medicare & Medicaid Services website. http://www.cms.hhs.gov/mcd/search.asp. Published June 19, 2006. Accessed June 10, 2025.
13. Local coverage determination: Glucose Monitors (L33822). Centers for Medicare and Medicaid Services website. https://www.cms.gov/medicare-coverage- database/search.aspx. Published October 1, 2015 (revised October 1, 2024). Accessed June 10, 2025.
14. National coverage determination. Treatment of psoriasis (250.1). http://www.cms.hhs.gov/mcd/search.asp. Published January 1, 1966. Accessed May 12, 2025.
15. Elmets CA, Lim HW, Stoff B, et al. Joint American Academy of Dermatology- National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis with phototherapy. J Am Acad Dermatol. 2019; 81(3):775-804.
16. Local coverage determination: Heating pads and heat lamps (L33784). Centers for Medicare and Medicaid Services website. https://www.cms.gov/medicare-coverage- database/search.aspx. Published October 1, 2015 (updated January 1, 2020). Accessed June 10, 2025.
17. Restraint and seclusion - Enclosure beds, side rails and mitts. The Joint Commission website. https://www.jointcommission.org/standards/standard- faqs/critical-access-hospital/provision-of-care-treatment-and-services-

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pc/000001668/. Published April 11, 2016 (updated April 5, 2024). Accessed June 10, 2025.

18. Enclosure bed: A protective and calming restraint. American Nurse Association website. https://www.myamericannurse.com/use-enclosure-beds/. Published January 13, 2015. Accessed June 10, 2025.
19. State Operations Manual Appendix A – Survey Protocol, Regulations and Interpretive Guidelines for Hospitals. Centers for Medicare & Medicaid Services. https://www.cms.gov/Regulations-and- Guidance/Guidance/Manuals/downloads/som107apahospitals.pdf. Published May 21, 2004 (revised April 19, 2024). Accessed June 10, 2025.
20. National coverage determination: Hospital beds (280.7). Centers for Medicare and Medicaid Services website. http://www.cms.hhs.gov/mcd/search.asp. Published January 1, 1966. Accessed June 10, 2025.
21. Evolving evidence review: ROMTech/PortableConnect (ROM Technologies Inc.) for telerehabilitation following total knee arthroplasty. Hayes. https://www.hayesinc.com/. Published August 15, 2024. Accessed June 10, 2025.
22. Local coverage determination. Cervical traction devices (L33823). Centers for Medicare & Medicaid Services website. http://www.cms.hhs.gov/mcd/search.asp. Published October 1, 2015 (revised January 1, 2020). Accessed June 10, 2025.
23. Kemker BP 3rd, Kankaria R, Patel N, Golladay G. Hip and Knee Bracing: Categorization, Treatment Algorithm, and Systematic Review. J Am Acad Orthop Surg Glob Res Rev. 2021;5(6):e20.00181-12. Published 2021 Jun 7. doi:10.5435/JAAOSGlobal-D-20-00181
24. Women’s Health and Cancer Rights Act (WHCRA). Centers for Medicare & Medicaid Services website. https://www.cms.gov/cciio/programs-and- initiatives/other-insurance-protections/whcra_factsheet. Women's Health and Cancer Rights Act (WHCRA) | CMS. Published September 10, 2024. Accessed May 13, 2025.
25. The World Professional Association for Transgender Health, Inc. (WPATH). Position statement on medical necessity of treatment, sex reassignment, and insurance coverage in the U.S.A. https://wpath.org/wp- content/uploads/2024/11/Transgender-Medical-Benefits.pdf. Published December 21, 2016. Accessed June 19, 2024.
26. Coleman E, Radix AE, Bouman WP, et al. Standards of Care for the Health of Transgender and Gender Diverse People, Version 8. Int J Transgend Health. 2022;23(Suppl 1):S1 to S259. Published 2022 Sep 6. doi:10.1080/26895269.2022.2100644
27. Clinical research response: IpsiHand (Neurolutions Inc.). Hayes. www.hayesinc.com. Published January 10, 2025. Accessed June 10, 2025.
28. Evidence Analysis Research Brief: Motus Hand and Foot Robotic-Assisted In- Home Devices for Stroke Recovery. Hayes. www.hayesinc.com. Published June 14,
29. Accessed June 10, 2025.
30. Local coverage determination. Facial Prostheses (L33738). Centers for Medicare & Medicaid Services website. http://www.cms.hhs.gov/mcd/search.asp. Published October 1, 2015 (revised January 1, 2020). Accessed June 10, 2025.

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30. National coverage determination. Infusion pumps (280.14). Centers for Medicare & Medicaid Services website. http://www.cms.hhs.gov/mcd/search.asp. Published December 17, 2004. Accessed June 10, 2025.
31. Local coverage article. External infusion pumps (L33794). http://www.cms.hhs.gov/mcd/search.asp. Published October 1, 2015 (revised October 1, 2024). Accessed June 10, 2025.
32. Local coverage determination. Suction pumps (L33612). Centers for Medicare & Medicaid Services website. http://www.cms.hhs.gov/mcd/search.asp. Published October 1, 2015 (revised January 1, 2024). Accessed June 10, 2025.
33. Local coverage determination. Vacuum erection devices (L34824). Centers for Medicare & Medicaid Services website. http://www.cms.hhs.gov/mcd/search.asp. Published October 1, 2015 (revised January 1, 2020). Accessed June 10, 2025.
34. Khera M. Treatment of male sexual dysfunction. UpToDate. www.uptodate.com. Published October 24, 2023. Accessed June 10, 2025.
35. Local coverage determination: Nebulizers (L33370). Centers or Medicare and Medicaid Services website. https://www.cms.gov/medicare-coverage- database/search.aspx. Published October 15, 2015 (revised January 1, 2024). Accessed June 10, 2025.
36. Local coverage determination. Oxygen and oxygen equipment (L33797). http://www.cms.hhs.gov/mcd/search.asp. Published October 1, 2015 (revised April 1, 2023). Accessed June 10, 2025.
37. Evidence analysis research brief: Volara (Hillrom) for respiratory therapy. Hayes. www.hayesinc.com. Published August 14, 2023. Accessed June 10, 2025.
38. Lauwers E, Ides K, Van Hoorenbeeck K, Verhulst S. The effect of intrapulmonary percussive ventilation in pediatric patients: A systematic review. Pediatr Pulmonol. 2018;53(11):1463 to 1474. doi:10.1002/ppul.24135
39. Huynh TT, Liesching TN, Cereda M, et al. Efficacy of Oscillation and Lung Expansion in Reducing Postoperative Pulmonary Complication. J Am Coll Surg. 2019;229(5):458 to 466.e1. doi:10.1016/j.jamcollsurg.2019.06.004
40. Aboussouan LS. Role of mucoactive agents and secretion clearance techniques in COPD. UpToDate. www.uptodate.com. Updated November 6, 2024. Accessed June 10, 2025.
41. Local coverage determination: Walkers (L33791). Centers for Medicare and Medicaid Services website. https://www.cms.gov/medicare-coverage- database/search.aspx. Published October 1, 2015 (revised January 1, 2020). Accessed June 10, 2025.
42. Local coverage determination: Manual wheelchair bases (L33788). Centers for Medicare and Medicaid Services website. https://www.cms.gov/medicare-coverage- database/search.aspx. Published October 1, 2015 (revised January 1, 2020). Accessed June 10, 2025.
43. Schiappa V, Piriano J, Bernhardt L, et al. RESNA Position on the Application of Seat-Elevation Devices for Power Wheelchair Users Literature Update. Rehabilitation Engineering and Assistive Technology Society of North America. https://www.resna.org/Portals/0/Documents/Position%20Papers/RESNA_App%20o

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f%20Seat%20Elevation%20Devices%202019.pdf. Published September 25, 2019. Accessed June 10, 2025.

44. Beaudoin M, Lettre J, Routhier F, Archambault PS, Lemay M, Gélinas I. Long-term use of the JACO robotic arm: a case series. Disabil Rehabil Assist Technol. 2019;14(3):267 to 275. doi:10.1080/17483107.2018.1428692
45. Evidence Analysis Research Brief: Jaco Assistive Robotic Arm (Kinova Inc.) for adults with Duchenne muscular dystrophy. Hayes. www.hayesinc.com. Published May 6, 2024. Accessed June 10, 2025.
46. Maughan KL., Jackson J. Ankle sprain in adults: Management. In: UpToDate, Grayzel J (Ed), (Last update June 28, 2024). Accessed December 23, 2024
47. Chapman J., Cohen J. Tibial and fibular shaft fractures in children. In: UpToDate. Wiley J (Ed), (Last update June 28, 2024). Accessed December 23, 2024
48. Gravlee JR., Hatch RL. Toe fractures in adults. In: UpToDate. Grayzel J (Ed), (Last update October 11, 2024). Accessed December 23, 2024
49. Hordon LD. Diabetic neuroarthropathy. In: UpToDate. Seo P (Ed), (Last update Jan 31, 2024). Accessed December 23, 2024
50. Centers for Medicare & Medicaid Services (CMS). Local Coverage Determination (LCD): Ankle-Foot/ Knee-Ankle-Foot Orthosis (L33686) Revision 8
51. Centers for Medicare & Medicaid Services (CMS). Local Coverage Article (LCA): Ankle-Foot/ Knee-Ankle-Foot Orthoses – Policy Article (A52457)
52. MCG, current edition (Ankle-Foot and Knee-Ankle-Foot Orthotics)
53. Horne JP., Flannery R., Usman S. Adolescent Idiopathic Scoliosis: Diagnosis and Management. American Family Physician. 2014 Feb 1;89 (3):193-198
54. Weinstein SL et al. Effects of Bracing in Adolescents with Idiopathic Scoliosis. N Engl J Med 2013 Oct 17; 369 (16):1512-1521
55. Negrini S., Donzelli, S., Aulisa, A.G. et al. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. International Society on Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT). Scoliosis and Spinal Disorders 2018 Jan 10; 13:3
56. Scherl S., Hasley B. Adolescent idiopathic scoliosis: Clinical features, evaluation, and diagnosis. In: UpToDate. Torchia MM (Ed), (Last update September 05, 2024). Accessed September 17, 2025
57. Scherl S., Hasley B. Adolescent idiopathic scoliosis: Management and prognosis. In: UpToDate. Torchia MM (Ed), (Last update July25, 2025). Accessed September 12 2025
58. Centene Policy CP.MP.48 Neuromuscular and Peroneal Nerve Electrical Stimulation (NMES) Version 06/2024
59. National coverage determination. Neuromuscular electrical stimulation (NMES) (160.12). Centers for Medicare and Medicaid Services website. http://www.cms.hhs.gov/mcd/search.asp. Published October 01, 2006. Accessed May 7, 2024.
60. Health Technology Assessment. Functional electrical stimulation for foot drop in acute or subacute phases of stroke recovery. Hayes. www.hayesinc.com. Published June 01, 2022 (annual review June 14, 2024). Accessed December 23, 2024.
61. Health Technology Assessment. Functional electrical stimulation (FES) for treatment of foot drop in multiple sclerosis patients. Hayes. www.hayesinc.com.

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Published November 17, 2021 (annual review November 26, 2024). Accessed December 23, 2024.

62. Doucet BM, Lam A, Griffin L. Neuromuscular electrical stimulation for skeletal muscle function. Yale J Biol Med. 2012;85(2):201 to 215.
63. Celli BR. Pulmonary rehabilitation. UpToDate. www.uptodate.com. Updated May 3, 2024. (Last update May 03, 2024). Accessed December 23, 2024.
64. Olek MJ, Narayan RN, Frohman EM, Frohman TC. Symptom management of multiple sclerosis in adults. UpToDate. www.uptodate.com. (Last update October 5, 2023). Accessed December 23, 2024.
65. de Freitas GR, Szpoganicz C, Ilha J. Does Neuromuscular Electrical Stimulation Therapy Increase Voluntary Muscle Strength After Spinal Cord Injury? A Systematic Review. Top Spinal Cord Inj Rehabil. 2018;24(1):6 to 17. doi:10.1310/sci16-00048
66. Jones S, Man WD, Gao W, Higginson IJ, Wilcock A, Maddocks M. Neuromuscular electrical stimulation for muscle weakness in adults with advanced disease. Cochrane Database Syst Rev. 2016;10(10):CD009419. Published 2016 Oct 17. doi:10.1002/14651858.CD009419.pub3
67. Sansare A, Harrington AT, Wright H, Alesi J, Behboodi A, Verma K, Lee SCK. Aerobic Responses to FES-Assisted and Volitional Cycling in Children with Cerebral Palsy. Sensors (Basel). 2021 Nov 15;21(22):7590. doi: 10.3390/s21227590. PMID: 34833666; PMCID: PMC8622737.

68. National Institute for Health and Care Excellence (NICE). Functional electrical stimulation for drop foot of central neurological origin [IPG278]. https://www.nice.org.uk/guidance/ipg278/chapter/2-The-procedure. Published January 28, 2009. Accessed May 7, 2024.

69. MCG, current edition . (Oxygen Therapy, Continuous and Noncontinuous: Home- 2009)
70. Patil, Susheel P., et al. Treatment of Adult Obstructive Sleep Apnea With Positive Airway Pressure: An American Academy of Sleep Medicine Systematic Review, Meta-Analysis, and GRADE Assessment. Journal of Clinical Sleep Medicine 15.02 (2019): 301-334.
71. Patil SP, Ayappa IA, Caples SM, Kimoff RJ, Patel SR, Harrod CG. Treatment of adult obstructive sleep apnea with positive airway pressure: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2019;15(2):335- 343
72. Gottlieb, Daniel J., and Naresh M. Punjabi. Diagnosis and Management of Obstructive Sleep Apnea: A Review. JAMA 323.14 (2020):1389-1400.
73. Veasey, Sigrid C., and Ilene M. Rosen. Obstructive sleep apnea in adults. New England Journal of Medicine 380.15 (2019): 1442-1449.
74. Richards, B.Stephens., and Katz, Donald E. Bracing for Scheurermann’s kyphosis. Revision June 2009
75. Nigrovic, Peter A. Back pain in children and adolescents: Causes. UpToDate. www.uptodate.com. (Last update August 15, 2024). Accessed January 20, 2025.
76. Nuchtern, Jed G and Mayer, Oscar H. Pectus carinatum and arcuatum. UpToDate. www.uptodate.com. Updated September 14, 2023. Accessed July 15, 2025.

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77. American Pediatric Surgical Association. Pectus Carinatum Guideline. https://www.pectusclinic.com/downloads/Pectus_Carinatum_Guideline_080812.pdf

78. Centene Policy CP.MP.107 Durable Medical Equipment and Orthotics and Prosthetics Guidelines Version 08/2025

    Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. “Health Plan” means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Fidelis Care, or any of such health plan’s affiliates, as applicable.

    The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures.

    This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time.

    This clinical policy does not constitute medical advice, medical treatment or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. This clinical policy is not intended to recommend treatment for members. Members should consult with their treating physician in connection with diagnosis and treatment decisions.

    Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan.

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CP.FC.06 DME Guidelines

This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited.
Providers, members and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members and their representatives agree to be bound by such terms and conditions by providing services to members and/or submitting claims for payment for such services.

Note: For Medicaid members, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy.

Note: For Medicare members, to ensure consistency with the Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs, LCDs, and Medicare Coverage Articles should be reviewed prior to applying the criteria set forth in this clinical policy. Refer to the CMS website at http://www.cms.gov for additional information.

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