Description:
Durable medical equipment is any equipment that meets ALL the following requirements:

1. Provides therapeutic benefits or enables the individual to perform certain tasks that he or she is unable to undertake otherwise due to certain medical conditions or illnesses
2. Can withstand repeated use
3. Is primarily and customarily used to serve a medical purpose
4. Generally is not useful to a person in the absence of an illness or injury
5. Is appropriate for use in the home but may be transported to other locations to allow the individual to complete instrumental activities of daily living (IADL), which are more complex tasks required for independent living

Moreover, DME must meet the following definitions of "durable" AND "medical equipment":

1. Durable — 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, lambs wool pads, catheters, ace bandages, elastic stockings, surgical face masks, irrigating kits, 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 benefit categories such as braces, prosthetic devices, artificial arms, legs, and eyes.
2. Medical Equipment — Medical equipment is equipment which is 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 determine 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 (hospitals, medical schools, medical societies) 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, 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.

Policy:
This health plan will provide coverage for durable medical equipment when all of the following criteria are met:

1. The requested item meets the definition of DME above.
2. The requested item has been ordered by a medical doctor; dentist (in conjunction with a medical doctor), osteopath, a physician's assistant, or a nurse practitioner.
3. The requested item has not otherwise been identified as not medically necessary or investigational per CAM Policy or contract language.
4. There is adequate documentation in the medical records or in the claim submission of ALL of the following:
   1. The documentation substantiates that the physician exercised prudent clinical judgment to order or provide this equipment for an individual for the purpose of preventing, evaluating, diagnosing or treating an illness, injury, disease or its symptoms, and in accordance with generally accepted standards of medical practice. Generally accepted standards of medical practice means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician specialty society recommendations and the views of physicians practicing in relevant clinical areas and any other relevant factors.
   2. There is a clinical assessment and associated rationale for the requested DME in the home setting as evaluated by a physician, licensed physical therapist, occupational therapist, or nurse.
   3. There is documentation substantiating that the DME is clinically appropriate, in terms of type, quantity, frequency, extent, site and duration and is considered effective for the individual's illness, injury or disease.
   4. The documentation supports that the requested DME will restore or facilitate participation in the individual's usual IADL's and life roles.
   5. The requested DME is not primarily for the convenience of the individual, physician, caregiver, or other health care provider.
   6. The DME is not more costly than an alternative service, sequence of services, device or equipment, at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that covered individual's illness, injury or disease.
   7. There is a Letter of Medical Necessity and/or prescription that is written by a physician, dentist (in conjunction with a medical doctor), osteopath, a physician's  assistant, or a nurse practitioner within the last three months of receipt of request.

The information should include the individual's diagnosis and other pertinent functional information, including, but not limited to, duration of the individual's condition, clinical course (static, progressively worsening, or improving), prognosis, nature and extent of functional limitations, other therapeutic interventions and results, past experience with related items, etc.).

Replacement Criteria for DME:

• The warranty date is more than two years old.
• There are specific malfunctions that prevent the item from functioning in a normal manner.

Requirements for DME Replacement:

• A Letter of Medical Necessity signed by the ordering provider indicating warranty information and specific malfunctions
• Ordering provider documentation that indicates a specific malfunction warranty documentation. Precertification history would count toward the warranty or clinical documentation that supports the member's diagnosis and treatment and when the member started using the requested DME. A physician statement would be acceptable.

Not Medically Necessary:

1. The item is intended to be used for athletic, exercise, or recreational activities as opposed to assisting the individual in the activities of daily living (either ADLs or IADLs).
2. The item is intended for environmental control or a home modification (e.g., electronic door openers, air cleaners, ramps, elevators, stair glides, wheelchair attachments or accessories for stair-climbing, etc.).
3. The item includes an additional feature or accessory, or is a non-standard or deluxe item that is primarily for the comfort and convenience of the individual.
4. The item is specifically designed for outdoor use (e.g., specially designed manual wheelchairs for beach access, specially designed power mobility devices for rough terrain, manual wheelchairs for sports, etc.).
5. The item represents a duplicative piece of equipment that is intended to be used as a backup device, for multiple residences, or for traveling, etc. (e.g., backup manual wheelchair when a power wheelchair is the individual's primary means of mobility, a second wheeled mobility device specifically for work or school use, car seats).
6. The item represents a product upgrade to a current piece of equipment that is either fully functional or replacement of a device when the item can be cost-effectively repaired.

The use of athletic/exercise/physical fitness equipment (e.g., treadmills or stationary bicycles such as ROMTech PortableConnect Adaptive Technology with telehealth supplementation) as an adjunct to comprehensive rehabilitation and/or conventional physical therapy is not established as effective and would be considered NOT MEDICALLY NECESSARY.

Reimbursement is to be limited to standard equipment.

Note: To the extent a particular type of DME is considered not medically necessary or investigational and not medically necessary, it may be addressed in a specific Medical Policy or Clinical UM Guideline.

BlueCross BlueShield of South Carolina will provide coverage for durable medical equipment when it is determined to be medically necessary. 

Coverage will be provided for repairs, parts and labor of eligible DME on an individual consideration basis when it is necessary to make the equipment usable.

BlueCross BlueShield of South Carolina will review the option to rent or purchase eligible DME on an individual basis, based on specific contract verbiage.

Rental or purchase of DME is paid only when the equipment has been delivered to the patient. Benefits are not reimbursed at the time the equipment is ordered.

Reimbursement is limited to standard equipment. BlueCross BlueShield of South Carolina does not cover "deluxe" items. A deluxe item is any equipment with operating expenses, including supplies, that are in excess of the cost of the standard equipment meeting the medical necessity requirements of the plan.

Reimbursement for maintenance agreements is the responsibility of the member and is not covered by BlueCross BlueShield of South Carolina.

****The below section will be effective on 01/01/2019**** 

Life Sustaining DME:
The following equipment is considered life sustaining and will be paid on a rental basis only:

Payment is based on the monthly fee schedule amounts until medical necessity ends. No payment will be made for the purchase of equipment, maintenance and servicing, or for replacement of these items. Supplies and accessories are not allowed separately.

****The above section will be effective on 01/01/2019**** 

REIMBURSEMENT FOR BACKUP VENTILATORS
This health plan includes payment for backup ventilators in the reimbursement for the primary ventilator, and no additional payment is made. If a backup ventilator is necessary, and is placed in the member's home, then the provider is responsible for supplying the backup ventilator.

A backup ventilator may be placed in the patient’s home so that a patient is prepared for equipment failure, disconnects and power outages. Most ventilators operate on household electric current but can also be battery-operated. Some have internal batteries. A backup battery should be readily available in case of power outages. In some areas, a backup generator is also advisable.

Repairs, parts and labor may be covered on an individual basis when it is necessary to make the equipment usable.

• The cost of the repairs should not exceed 50 percent of the purchase of a new piece of equipment.
• The cost of "loaner" rental equipment may be allowed while the "broken" item is being repaired.

Replacement or repair of an item that has been misused or abused by the member or member's caregiver/family will be the responsibility of the member.

Durable medical equipment will be considered "under warranty" for two years after initial rental or purchase.

DME and prosthetics/orthotic fees include:

• Delivery and/or installation.
• Sales tax.
• Casting, molding, fabrication, fitting and/or adjustments.
• Materials and hardware (i.e., screws, bolts, etc.).
• Labor (with the exception of medically necessary repairs after the warranty period).

DME rental fees WILL COVER:

• Cost of repairs, replacements, adjustments, supplies and accessories.
• Equipment delivery and setup.

Education and training for patient and family are NOT ELIGIBLE for separate reimbursement.  

Durable medical equipment and services are not covered under the following criteria:

• Optional or ancillary DME equipment/features are intended primarily for convenience or upgrades beyond what is necessary to meet the member's legitimate medical needs. Deluxe items are not a covered benefit. Reimbursement will be limited to the allowance for standard model equipment.
• When it does not provide a therapeutic benefit to a patient or is not medically necessary.
• When the equipment has not been prescribed by a physician.
• When the item is primarily for comfort, convenience or hygienic purposes.
• When the equipment is used in a facility that is expected to provide such items (e.g., nursing home).
• Devices/equipment used to enhance the environmental setting (e.g., air conditioners, air filters and portable whirlpool spa pumps. These items are not primarily medical in nature).
• Equipment delivery and/or setup, education and training for the patient/family is included in the allowance for the equipment and is NOT eligible for separate reimbursement.
• Items not requiring a physician's order and that can be purchased as an "over-the-counter" item, with the exception of diabetic supplies, are not a covered benefit.

Rental versus purchase:
Rental versus purchase coverage is based on the item prescribed, the patient's prognosis, the time frame required for use and the total cost (rental vs. purchase) for the equipment.

When the DME is purchased, the total benefits available cannot exceed the contracted fee schedule.

When the DME is rented, the benefits cannot exceed the total of the cost to purchase the equipment or the contracted fee schedule.

Rental equipment that has reached a maximum reimbursement (rental paid up to the purchase price) will become the property of the member and will remain in the patient's possession. The DME provider may charge separately for supplies, as well as for repairs, parts and labor that are necessary for the function of the equipment.

Equipment that is purchased without prior rental will be owned by the patient/member.

Equipment Provided By a Physician's Office or Outpatient Hospital:
Equipment provided by a physician's office, such as crutches, braces, etc., may be allowed at a cost not exceeding the allowable that would be paid to a retail supplier. Take-home supplies, such as adhesive bandages, Ace bandages and extremity binders that are over-the-counter, are not a contract benefit. These supplies must meet the same criteria for coverage as supplies purchased from a retail outlet.

Compression stockings are considered MEDICALLY NECESSARY for the following conditions and/or complications:

• Prevent scarring, contractures or edema resulting from a fracture or burn injury
• Venous stasis ulcers (stasis ulcers)
• Prevention of thrombosis in an immobilized person (e.g., immobilization due to surgery, trauma or general debilitation, etc.)
• Post thrombotic syndrome (post phlebitic syndrome)
• Chronic intractable lymphedema

**This applies only to pre-made or custom-made pressure gradient support stockings (e.g., Jobst, SigVarus, Venes, etc.) that have a pressure of 18 mm Hg or more, that require a physician's prescription, and that require measurements for fitting.** Typically, only one to two pair of stockings are necessary every three to six months. However, no more than eight pair per year will be reimbursed.

Vascular Compression Units (VCU), utilized postoperatively for cold/compression therapy, as well as DVT and PE prevention, including, but not limited to, ThermoTek, VascuTherm 2, VascuTherm 3, ThermaCare, are considered NOT MEDICALLY NECESSARY.

This health plan typically follows National and Local Medicare and DMERC policies, except where specifically addressed in the Policy Manual. Reimbursement for maintenance/service agreements is the responsibility of the member and is not a covered benefit.

All DME is subject to medical necessity. Please see specific contract verbiage related to exclusions, limitations and precertification requirements.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

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